Rocket Medical R29700 Manual

OPERATORS GUIDE
Oocyte Aspiration Pump

Oocyte Aspiration Pump –Operators Guide
2
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
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: .....................................................................................................................................................................5
2.5. SERVICE AGENTS:....................................................................................................................................................................5
2.6. GENERAL DESCRIPTION:.........................................................................................................................................................6
2.7. INTENDED USE:.........................................................................................................................................................................6
2.8. CONTRAINDICATIONS: .............................................................................................................................................................6
2.9.CLASSIFICATION........................................................................................................................................................................6
2.10. REFERENCES:.........................................................................................................................................................................6
3. SAFETY INSTRUCTIONS..............................................................................................................................................7
• POWER SUPPLY:.......................................................................................................................................................................7
• CONSUMABLES:........................................................................................................................................................................7
• TERMINOLOGY:.........................................................................................................................................................................7
• WARNINGS:................................................................................................................................................................................8
• SUPPLY VOLTAGE SELECTION...............................................................................................................................................9
• ELECTROMAGNETIC COMPATIBILITY ....................................................................................................................................9
• PACKAGING...............................................................................................................................................................................9
• POSITIONING and PLACEMENT of theDEVICE.......................................................................................................................9
• SYMBOLS USED ON OOCYTE ASPIRATION PUMP..............................................................................................................10
• SYMBOLS USED ON POWER SUPPLY UNIT.........................................................................................................................11
• SYMBOLS USED ON R57686 FILTER SET FOR OOCYTE ASPIRATION PUMP . ................................................................11
4. OPERATING THE PUMP .............................................................................................................................................12
4.1. TABLE 1 RECOMMENDED SUCTION SETTINGS...................................................................................................................13
4.2. PUMP SET-UP PROCEDURE SCHEMATIC............................................................................................................................15
4.3. PROCEDURE ...........................................................................................................................................................................16
5. CONSUMABLES...........................................................................................................................................................17
5.1. PATIENT CONNECTION SET DISPOSAL................................................................................................................................17
6. CLEANING THE PUMP CASING .................................................................................................................................18
7. SERVICE INDICATOR..................................................................................................................................................18
8. RETURNING THE PUMP FOR SERVICE:...................................................................................................................18
9. YEAR OF MANUFACTURE:.........................................................................................................................................19
10. STORAGE & TRANSPORTATION:........................................................................................................................19
11. OPERATING ENVIRONMENT: ..............................................................................................................................20
12. WARRANTY............................................................................................................................................................21
13. DISPOSAL: .............................................................................................................................................................21
14. TECHNICAL SPECIFICATIONS.............................................................................................................................22
14.1.CLASSIFICATION....................................................................................................................................................................22
14.2. SPECIFICATIONS............................................................................................................................................................22
14.3. EMC Tables:.....................................................................................................................................................................23

Oocyte Aspiration Pump –Operators Guide
3
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
1. GENERAL ASSEMBLY
1. Touch sensitive Suction Control Dial –clockwise to increase, anticlockwise to decrease the setvalue
2. Suction Display in mmHg-1
3. Patient connection port –only for use with R57686 Filter Set for Oocyte Aspiration Pump
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: MPU30
12. Power cords, IEC UK & EC types.

Oocyte Aspiration Pump –Operators Guide
4
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
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.
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 partwithout
the approval of Rocket® Medical plc.
2.2. MODEL NUMBERS:
Pump: R29700. Power Supply: MPU30
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
Revision 22
Correction of mains voltage statement, Sterile Statement
10/08/16
Revision 23
Update Service Agents & Warranty period & EU Rep.
25/02/19
Revision 24
Revision 25
Revision 26
Update to include FDA Rx only symbol
Update to Service Agents and CE mark
Addition of Italian
21/05/19
19/08/20
14/01/21
Revision 27
Update to Section 4.3 and Product Name Change
08/03/21

Oocyte Aspiration Pump –Operators Guide
5
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
2.4. MANUFACTURER:
Rocket Medical plc
Sedling Road
WASHINGTON
Tyne & Wear NE38 9BZ.
UK.
CAUTION:
Any adjustment,
modification or repairs
to the equipment
should only be carried
out by authorised
service agents.
2.5. SERVICE AGENTS:
UK & European Service Agents:
IVFSynergy Ltd.,
Old School,
Tresillian,
Cornwall
TR2 4BA
Tel: [phone]
Email: [e-mail]
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: [e-mail]
Website: www.dtsqtech.solutions
Rocket Medical GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany

6
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
Rocket® Oocyte Aspiration Pump –Operators Guide
2.6. GENERAL DESCRIPTION:
The 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 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 and the Human Fertilisation & Embryology Authority.
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 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 Genetics Volume 6, Number
6 / December, 1989

7
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
Rocket® Oocyte Aspiration Pump –Operators Guide
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 thetechnique.
• POWER SUPPLY:
The device is only for use with power supply Model Number: MPU30. 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.
• CONSUMABLES:
The device must only be used with R57686 Filter Set for Oocyte Aspiration Pump. 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.
• 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.

8
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
Rocket® Oocyte Aspiration Pump –Operators Guide
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.
• 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 practiceguidelines.
• The device is not approved for connection to any other device except the R57686
Filter Set for Oocyte Aspiration Pump
• The R57686 Filter set for Oocyte Aspiration Pump is single use and its instructions
for use must be followed at all times.
• Do NOT use the R57686 Filter set for Oocyte Aspiration Pump if the packaging is
broken.
• Do not use in an area where flammable gases are present.
• Regular periodic maintenance of the device is recommended as indicated by the
service indicator.
• 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 the device.
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 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: MPU30.
• 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 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 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 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 setconfigurations.

9
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
Rocket® Oocyte Aspiration Pump –Operators Guide
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.
• 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 100V to 240 VAC @ 50 / 60Hz
Ensure that the correct power cord is connected.
• ELECTROMAGNETIC COMPATIBILITY
The 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 otherstrong
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.
• 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 servicingwhen
required.
• POSITIONING and PLACEMENT of the DEVICE
The 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 +40°C

10
Copyright© 2009-2021 Rocket® Medical plc .
All rights reserved.
ZDOCK193
Rev:27
2021-03-08
Rocket® Oocyte Aspiration Pump –Operators Guide
• 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 achievedwith
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