Rocket R29700 Manual

OPERATORS GUIDE
Rocket® Oocyte Aspiration Pump

Rocket® Oocyte Aspiration Pump –Operators Guide
2 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
1.
CONTENTS
1. GENERAL ASSEMBLY.................................................................................................................................................3
2. GENERAL INFORMATION...........................................................................................................................................4
2.1. COPYRIGHT............................................................................................................................................................................ 4
2.2. MODEL NUMBERS:................................................................................................................................................................. 4
2.3. MANUAL REVISION: ............................................................................................................................................................... 4
2.4. MANUFACTURER: .................................................................................................................................................................. 4
2.5. SERVICE AGENTS:................................................................................................................................................................. 4
2.6. GENERAL DESCRIPTION:...................................................................................................................................................... 5
2.7. INTENDED USE:...................................................................................................................................................................... 5
2.8. CONTRAINDICATIONS: .......................................................................................................................................................... 5
2.9. CLASSIFICATION.................................................................................................................................................................... 5
2.10. REFERENCES:...................................................................................................................................................................... 5
3. SAFETY INSTRUCTIONS............................................................................................................................................6
3.1. POWER SUPPLY:.................................................................................................................................................................... 6
3.2. CONSUMABLES:..................................................................................................................................................................... 6
3.3. TERMINOLOGY:...................................................................................................................................................................... 6
3.4. WARNINGS:............................................................................................................................................................................. 7
3.5. SUPPLY VOLTAGE SELECTION............................................................................................................................................ 8
3.6. ELECTROMAGNETIC COMPATIBILITY ................................................................................................................................. 8
3.7. PACKAGING............................................................................................................................................................................ 8
3.8. POSITIONING and PLACEMENT of the DEVICE.................................................................................................................... 8
3.9. SYMBOLS USED ON OOCYTE ASPIRATION PUMP............................................................................................................. 9
3.10. SYMBOLS USED ON POWER SUPPLY UNIT.................................................................................................................... 10
3.11. SYMBOLS USED ON R57686 PATIENT CONNECTION SET. ........................................................................................... 10
4. OPERATING THE PUMP ...........................................................................................................................................11
4.1. TABLE 1 RECOMMENDED SUCTION SETTINGS ............................................................................................................... 12
4.2. PUMP SET-UP PROCEDURE SCHEMATIC......................................................................................................................... 14
4.3. PROCEDURE......................................................................................................................................................................... 15
5. CONSUMABLES.........................................................................................................................................................16
5.1. DISPOSAL: ............................................................................................................................................................................ 16
6. CLEANING THE PUMP CASING ...............................................................................................................................17
7. SERVICE INDICATOR................................................................................................................................................17
8. RETURNING THE PUMP FOR SERVICE:.................................................................................................................17
9. YEAR OF MANUFACTURE:.......................................................................................................................................18
10. STORAGE:................................................................................................................................................................18
11. TRANSPORTATION:................................................................................................................................................19
12. WARRANTY..............................................................................................................................................................20
13. DISPOSAL: ...............................................................................................................................................................20
14. TECHNICAL SPECIFICATIONS...............................................................................................................................21
14.1. CLASSIFICATION................................................................................................................................................................ 21
14.2. SPECIFICATIONS................................................................................................................................................................ 21
14.3. EMC Tables:......................................................................................................................................................................... 22

Rocket® Oocyte Aspiration Pump –Operators Guide
3 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
1.
GENERAL ASSEMBLY
1. Touch sensitive Suction Control Dial –clockwise to increase, anticlockwise to decrease the set value
2. Suction Display in mmHg-1
3. Patient connection port –only for use with R57686 Rocket® Oocyte Aspiration Pump Patient Connection Sets
4. Power On Indicator LED (Green, 12VDC)
5. Footswitch connection ports
6. User Set Suction Indicator LED (Blue,50-300mmHg-1)
7. Pre-set (Max) Suction Indicator LED (Orange, 500mmHg-1)
8. Service Indicator LED (Yellow)
9. O/I 12V Power On/Off switch
10. Dual footswitch –air controlled
Not shown:
11. Power Supply Unit (PSU) Model: MPU30B-3
12. Power cords, IEC UK & EC types.

Rocket® Oocyte Aspiration Pump –Operators Guide
4 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
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.
CAUTION:
Any adjustment,
modification or repairs
to the equipment
should only be carried
out by authorised
service agents.
2.
GENERAL INFORMATION
2.1.
COPYRIGHT
This manual contains information that is subject to copyright. All rights reserved. This
manual should not be photocopied, duplicated or distributed completely or in part without
the approval of Rocket® Medical plc.
2.2.
MODEL NUMBERS:
Pump: R29700. Power Supply: MPU30B-3
2.3.
MANUAL REVISION:
Revision 1: First Release 11/12/09
Revision 2: Update to Tube Set image 15/03/10
Revision 3: Pre-evaluation corrections & update 11/08/10
Revision 4 Correction to pedal designations 16/08/10
Revision 5 Addition of set-up schematic 09/05/11
Revision 6 Update to accuracy statement 19/05/11
Revision 7 Addition of ZDOCK code and © statement 15/06/11
Revision 8 Service intervals 14/07/11
Revision 9 Symbol tables and storage conditions 27/10/11
Revision 10 CE mark, year of manufacture statement 21/11/11
Revision 11 PSU markings, EMC statement added 08/12/11
Revision 12 Addition of Classification statements 20/12/11
Revision 13 Amendment to vacuum type 13/02/12
Revision 14 Amendment to control increments 08/03/12
Revision 15 Updated cover images 07/01/13
Revision 16 Standardisation of accuracy limits 13/08/13
Revision 17 Update to images and latex statement, symbol. 06/11/13
Revision 18 Update: power consumption, YOM, footer 16/07/14
Revision 19 Amend CE mark 27/08/14
Revision 20 Addition of procedural instructions, EMC data. 17/06/16
Revision 21 Addition of symbols and warning statements 17/06/16
2.4.
MANUFACTURER:
Rocket Medical plc
Sedling Road
WASHINGTON
Tyne & Wear NE38 9BZ. UK.
2.5.
SERVICE AGENTS:
Customer Services:
Rocket® Medical plc.
Sedling Road. WASHINGTON. NE38 9BZ. ENGLAND
Tel: [phone]. Fax: [phone]
Email: [e-mail]
US Office:
Rocket® Medical
Unit 1. 150 Recreation Park Drive. HINGHAM. MA 02043. USA
Tel: [phone]. Fax: [phone]. Email: [e-mail]

Rocket® Oocyte Aspiration Pump –Operators Guide
5 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
2.6.
GENERAL DESCRIPTION:
The Rocket® Oocyte Aspiration Pump has been developed to provide smooth, low
volume/high suction (vacuum) at a pre-determined negative pressure. Suction is activated
by a foot operated toggle air switch controlled by the surgeon performing the oocyte
collection.
The range of suction is variable from 50-300mmHg-1 and at a pre-set 500mmHg-1 in ‘Max’
suction mode.
The Rocket® Oocyte Aspiration Pump requires a disposable filter set.
2.7.
INTENDED USE:
A device for the generation of low volume/high (vacuum) suction of between 50-300
mmHg-1 to permit the aspiration of follicular fluid, oocytes and ovarian fluid as part of the
treatment for infertility relating to IVF and other related procedures.
This device should 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.
2.8.
CONTRAINDICATIONS:
Not intended for use where ovarian aspiration or the aspiration of ovarian fluid is
contraindicated such as patients with vaginal infections, sexually transmitted diseases,
suspected pregnancy and where the pelvic anatomy cannot be accurately assessed by
ultrasonography. Not intended for surgical suction or other applications.
2.9.
CLASSIFICATION
IEC 60601-1
Type of protection against electric shock: Class II
Degree of protection against electric shock: Type B
Vacuum type: high vacuum/low volume
Suitable for continuous operation.
Not suitable for use in the presence of flammable gases.
Not suitable for use in conditions which expose the device to the ingress of fluids.
Not suitable for sterilisation
2.10.
REFERENCES:
Craft I, McLeod F. Edmonds K, ‘Human embryo transfer technique’. Lancet 1961 ii 1104-5
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 Medicine 90-102
Reeves G, Scott R T, et al (1989) Journal of Assisted Reproduction and Genetics Volume 6, Number
6 / December, 1989

Rocket® Oocyte Aspiration Pump –Operators Guide
6 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING:
This device should only
be operated by
appropriately qualified
personnel.
3.
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 before use.
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.
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 the technique.
3.1. POWER SUPPLY:
The device is only for use with power supply Model Number: MPU30B-3.Attachment of any
other power supply may severely damage the device.
CAUTION: Disconnection from the mains supply can only be achieved with the removal of
the mains power lead from the wall socket.
3.2. CONSUMABLES:
The device must only be used with R57686 Rocket® Oocyte Aspiration Pump Patient
Connection Sets. The use of non-approved tubing or filter sets may impair pump
performance, lead to increased risk to patients and harvested oocytes and will invalidate
the Warranty.
The hydrophobic filter sets are designed to prevent fluid contamination of the suction
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.
3.3. TERMINOLOGY:
Throughout this manual the term “suction” is used to denote aspiration of fluid with vacuum
or negative pressure. The use of the term ‘suction’ is in observance of the requirements of
the ISO6061-1 Standard as amended.

Rocket® Oocyte Aspiration Pump –Operators Guide
7 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
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.
3.4. 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 User Manual.
This device should only be used by, or under the supervision of, appropriately
trained personnel and in conjunction with current local clinical practice guidelines.
The device is not approved for connection to any other device except the Rocket
R57686 Aspiration set.
The Rocket R57686 Aspiration set is single use and its instructions for use must
be followed at all times.
Do not use in an area where flammable gases are present.
Regular periodic maintenance of the Oocyte device is recommended as indicated
by the service indicator..
Precautions for EMC safety should be observed. The Oocyte Device complies with
IEC60601-1-2:2012 for use in a Professional healthcare facility however:
oElectronic equipment in the vicinity of the Oocyte device may affect its
operation and potentially cause unpredictable operation of the device.
oWherever possible the Oocyte device should be distanced from
surrounding electromagnetic equipment and cables to this equipment in
order to reduce possible electromagnetic interference.
oThe Oocyte 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 Rocket Medical..
When positioning the unit, ensure that access is available to the DC power cable
located on the rear of the unit.
To avoid damage to the unit only use the approved mains power adaptor supplied
with the unit, Model Number: MPU30B-3.
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 the procedure.
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 authorised representative.
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 in harvesting
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 suction applied.
Therefore, the 500mmHg-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 set configurations.

Rocket® Oocyte Aspiration Pump –Operators Guide
8 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING:
ELECTRIC SHOCK
HAZARD.
This device is only for
use with electrical
systems complying with
the appropriate 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.
3.5. SUPPLY VOLTAGE SELECTION
The device operates at a voltage of 12VDC supplied via a universal medical grade power
supply unit (PSU).
Input voltage: 12VDC
Universal power supply range 100–240VAC, 50/60Hz. 0/8-0.4W. 0.096KW/h
Ensure that the correct power cord is connected.
3.6. ELECTROMAGNETIC COMPATIBILITY
The Rocket® Oocyte Aspiration Pump complies with the electromagnetic compatibility
(EMC) limits for medical devices as specified by EN60601-1-2:2015. These limits are
designed to provide a reasonable degree of protection against harmful interference found
in typical medical installations.
Medical electrical equipment requires special precautions regarding EMC and the device
must be installed, positioned and operated according to the instructions contained in this
manual to ensure continued electromagnetic compatibility.
It is possible that high levels of radiated or conducted radio-frequency electromagnetic
interference (EMI) from portable and mobile RF communications equipment or other strong
or nearby radio-frequency sources could result in performance disruption of the suction
pump.
Evidence of EMC interference may include erratic digital displays, an inability to correctly
set the desired suction, the device failing to operate, or other incorrect functioning.
If this occurs, stop using the aspiration pump and contact Customer Services or Rocket®
Medical authorised distributor.
3.7. PACKAGING
The packaging has been carefully designed to allow secure transportation of the pump and
its accessories.
After unpacking, re-assemble and retain the packaging for transport for servicing when
required.
3.8. POSITIONING and PLACEMENT of the DEVICE
The Rocket® Oocyte Aspiration Pump must be placed on a secure, level surface, away
from sources of heat, water splashes, mists or cooling vents and with due regard to EMC
protection (Section 4.6)
Do not expose to direct sunlight.
Do not expose to flammable gases.
Operating temperature Range: +5°C and +35°C

Rocket® Oocyte Aspiration Pump –Operators Guide
9 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
3.9. SYMBOLS USED ON OOCYTE ASPIRATION PUMP.
12 V DC Power ON/OFF.
This device operates on 12V DC power provided by a
separate power supply module supplied with the device.
Disconnection from the mains supply can only be achieved
with the removal of the mains power lead from the wall socket.
This device is Type B
Connection point for filter set
Footswitch connection
This device is powered by a Class II
power supply unit.
Indicates the Service Interval Indicator
Suction Display Touch control symbol.
Indicates activation of the pre-set (Max) 500mmHg-1 mode
Indicates activation of the user set 50-300mmHg-1 mode
Dispose of this device in accordance with
WEEE directive (2002/96/EC)
CE Mark
Consult the Instructions for Use
CAUTION: consult accompanying documents
SN
Indicates device serial number
Indicates manufacturer

Rocket® Oocyte Aspiration Pump –Operators Guide
10 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
3.10. SYMBOLS USED ON POWER SUPPLY UNIT.
Read the manual before connection and use
WARNING: Risk of electric shock.
The PSU should not be opened
Device is only for use indoors
Class II Power Supply Unit
12V DC connection polarity
Dispose of this device in accordance with
WEEE directive (2002/96/EC)
PSU conforms to EN60601-1 & IEC60601-1
CE Mark
3.11. SYMBOLS USED ON R57686 PATIENT CONNECTION SET.
Read the Instruction for Use before connection and use
Device is for Single Use Only
Batch number for sterile device
Device is sterilised by Ethylene Oxide
The device is not manufactured with natural latex
CE Mark

Rocket® Oocyte Aspiration Pump –Operators Guide
11 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
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
4.
OPERATING THE PUMP
1. Unwrap the footswitch and attach the air tubing to
the male/female ports on the underside of the pump
casing. The footswitch is normally left attached to
unit in daily use unless removal for storage is
required.
2. Connect the correct mains lead to the 12V power
supply module - Model number: MPU30B-3 and
connect to an electrical supply 110-240VAC
50/60Hz. The power supply module is self-regulating
to generate 12VDC.
3. Turn the power switch 0-I (rear panel) to on. The
green LED (indicated) on the front panel will
illuminate.
4. The main display will display an initial value of
100mmHg-1
5. Using aseptic technique, un-pack the R57686
Rocket® Oocyte Aspiration Pump Filter Set and
attach the short length of silicone tubing to the spigot
(indicated). The tubing should be a light push-on fit.
6. Pass the longer patient connection tube into the
operative field. The filter set is for single patient use
and must be replaced for each patient.
NOTE: The hydrophobic filter set is specially
designed to prevent ingress of fluid to the pump.
If the filter material becomes contaminated with
fluid it will occlude thereby protecting the pump
mechanism. Immediately replace the filter set if it
becomes contaminated and between every
patient.
The pump must NOT be operated without the
correct filter set attached.
Operation without the correct filter set will
invalidate the Warranty.

Rocket® Oocyte Aspiration Pump –Operators Guide
12 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING:
Ensure the set suction
level is appropriate to
the patient’s needs and
has taken into
consideration the
needle and tube set
configuration
7. On Start-Up, the pump is pre-set to 100mmHg-1
suction. To increase this value, use a circular motion,
lightly drawing a finger clockwise over the outer zone
of the control dial in the direction of the arrows.
8. Refer to Table 1 for recommend values for various
needle and tube set combinations
9. The active dial zone will sense the motion and
increase the display in 5mmHg-1 increments.
10. To decrease the set value, use an anticlockwise
circular motion.
11. When the desired value is reached, hold the finger
still for 2 seconds when an audible ‘beep’ will confirm
the new setting.
12. If the new setting is not correctly saved, the value will
return to its previous set value in 10 seconds.
13. If the new value has not been stored, repeat from #7.
4.1.
TABLE 1 RECOMMENDED SUCTION SETTINGS
14. 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.
15. The luer connection is also suitable for connection to
other standard ISO 6% luer taper adaptors and
fittings.
Single Lumen
Double Lumen
16G
17G
16G
17G
Tube Set Length
Recommended Suction -mmHg
55cm
80
110
130
150
70cm
90
130
150
170
90cm
100
150
170
190

Rocket® Oocyte Aspiration Pump –Operators Guide
13 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING:
HIGH SUCTION MODE
must NOT be used to
aspirate oocytes as this
may result in damage
to the oocyte and lead
to reduced fertilisation
rates.
HIGH suction settings
may only be used to
clear blockages from
a needle set and must
NOT be used in
contact with the
patient.
16. The footswitch control operates on a toggle switch.
Depress a pedal once for ON and depress again for
OFF. A tone will sound to indicate activation of the
footswitch.
17. To activate the suction pump to deliver the set value
–depress the WHITE pedal once.
18. Once activated, the pump will commence to deliver
the suction level previously set. The display indicates
the actual suction set by the user.
19. The blue LED will illuminate and flash rapidly to
confirm suction (50-300mmHg-1) is active.
20. To stop suction, depress the pedal once again. The
pump will immediately stop and vent to air and the
user set suction LED will go out.
21. To activate the pre-set Max suction, depress the
BLACK Pedal once –the pump will immediately
deliver a nominal suction of 500mmHg-1
22. Both suction indicator LED’s will illuminate.
23. To stop max suction, depress the BLACK pedal once
or depress the WHITE pedal to continue to evacuate
at the previously set suction level.

Rocket® Oocyte Aspiration Pump –Operators Guide
14 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
4.2.
PUMP SET-UP PROCEDURE SCHEMATIC

Rocket® Oocyte Aspiration Pump –Operators Guide
15 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING
This device should only
be used by, or under
the supervision of,
appropriately trained
personnel in
conjunction with clinical
practice guidelines
4.3.
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 during the
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 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 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. 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.
5. Locate the bung/stopper and attach to a
sterile sample tube.
6. Connect the tubing connector to pateint connection port (see Section 4)
7. Aspirate 2-5ml of flushing media into the tube and discard.
8. Assemble the needle into the needle guide following the manufacturers instructions.
The diagram above shows a common probe and needle assembly.
9. Set the vacuum level to your personal preference using the values in Table 1 as a
guide.
10. Ensure all connections are air tight and the tube set is free from any constrictions as
these cause turbulence 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, 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 the other.

Rocket® Oocyte Aspiration Pump –Operators Guide
16 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
WARNING: This device
must only be operated
with approved
consumables which are
specifically designed to
provide the correct flow
rates and protect the
device from ingress of
liquid.
Should any liquid
enter the device,
discontinue use
immediately and
refer to an
authorised
service agent
5.
CONSUMABLES
Description
Code
Rocket® Oocyte Aspiration Pump Patient Connection Set
5µm filter set, 2.5m patient connection tube with male luer connector. Supplied
sterile, for single use in cartons 10 units.
R57686
5.1.
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.

Rocket® Oocyte Aspiration Pump –Operators Guide
17 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
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
6.
CLEANING THE PUMP CASING
At the end of each clinical session, turn off the device at the rear panel and disconnect
the PSU from mains power supply
Using an aqueous 70% alcohol solution (eg. IMS or isopropyl BP) solution, 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 an alcohol solution.
Do NOT use a 100% alcohol or any other solvent to clean the device as this may cause
damage to the casing surface and display.
Prevent any fluid from entering the device.
7.
SERVICE INDICATOR
Service intervals are based on 1000 hours of pump
operating time measured when the unit is providing
suction. This equates to approximately 3000
aspiration cycles before the pump requires servicing.
The Service Indicator LED (arrowed) will remain
illuminated indicating the pump now requires
servicing. After 50 hours of usage without servicing,
the Service Indicator will flash continuously indicating
servicing is now overdue.
Illumination of the service indicator does not inhibit
pump function.
Once illuminated, the pump must be returned for
servicing as soon as possible.
8.
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 Section 8 above
2. Seal in a plastic bag and seal within a second plastic bag.
3. Place in the original packaging.
4. Enclose the following information:
•Contact name
•Centre address
•Decontamination Certificate
•Description of the fault or service required
•Accompanying Order to authorise servicing –contact your local Customer
Services Team for details

Rocket® Oocyte Aspiration Pump –Operators Guide
18 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
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 in 2011
For units manufactured after 01/04/14, the year of manufacture is
shown on the rear rating plate label opposite the model number.
10.
STORAGE & TRANSPORTATION:
The device must be transported/stored at temperatures between
-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 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

Rocket® Oocyte Aspiration Pump –Operators Guide
19 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
11.
OPERATING ENVIRONMENT:
The device must be operated at temperatures between +5°C to +
40°C
The device must be operated at relative humidity levels between
15% to 93%
The device must be operated at ambient pressure levels between
70kPa to 106kPa.
The device is FRAGILE and must be transported in its original
packaging to ensure protection.
If the original packaging is not available please contact your local
Customer Services Agent who will provide replacement packaging.
Dimensions:
W - 248mm
H - 86mm
D - 194mm
Weight:
Unit –2.56Kg
Footswtich –0.51Kg
Protect the device from ingress of liquid. Should any liquid enter the
device, discontinue use immediately and refer to an authorised
service agent

Rocket® Oocyte Aspiration Pump –Operators Guide
20 Copyright© 2009-2016 Rocket® Medical plc . All rights reserved. ZDOCK193 Rev:21 17/06/16
Where
applicable, disposal of
this device must be
undertaken with regard
to the WEEE directive
(2002/96/EC).
12.
WARRANTY
Rocket® Oocyte Aspiration Pumps are sold by Rocket Medical plc under the warranties
set forth in the following paragraphs. Such warranties are extended only with respect to the
purchase of the Products directly from Rocket Medical plc as new merchandise and are
extended to the first Buyer thereof, other than for resale.
For a period of twelve (12) months from the date of shipment the Products are warranted
to be free from functional defects in materials and workmanship and to conform to the
description of the Products contained in the operating manual and accompanying labels,
provided the same is properly operated under conditions of normal use, that annual
maintenance and service is performed at an authorised Rocket Medical plc service facility
Removal of any QC seal voids the warranty.
The foregoing warranties shall not apply if the Products have been repaired other than by
Rocket Medical plc or other than in accordance with written instructions provided by
Rocket Medical plc , or altered by anyone other than Rocket Medical plc, or if the
Products have been subject to misuse, negligence, or accident.
Rocket Medical plc 's sole and exclusive obligation and Buyer's sole and exclusive
remedy under the above warranties is limited to repairing or replacing, free of charge, at
Rocket Medical plc 's option, Products, which are reported to Rocket Medical plc by
mail, telephone or email and which, if so advised by Rocket® Medical plc, is thereafter
returned with a statement of the observed deficiency, not later than seven (7) days after
the expiration date of the warranty, to Rocket Medical plc during normal business
address, transport charges prepaid and which, upon Rocket Medical plc's examination, is
not found to conform with the above warranties.
Rocket Medical plc shall not be otherwise liable for any damages including but not limited
to incidental damages, consequential damages or special damages.
There are no express or implied warranties which extend beyond the warranties herein
above set forth. Rocket Medical plc makes no warranty of merchantability or fitness for a
particular purpose with respect to the Products or parts thereof.
13.
DISPOSAL:
At the end of the service life of the equipment, this device should be disposed of in
accordance with WEEE directive (2002/96/EC as amended)and 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.