rocketcraft_oocyte_aspiration_pumps_service_manual_.pdf
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SERVICE MANUAL
Rocket CRAFT™
Oocyte Aspiration Pumps
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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual
1. CONTENTS
1. CONTENTS..................................................................................................................................................................................... 2
2. GENERAL ASSEMBLY ................................................................................................................................................................... 3
2.1. Rocket CRAFT™ DUO-VAC Suction Pump ............................................................................................................................. 3
2.2. Rocket CRAFT™ DUO-VAC Suction Pump – Internal View .................................................................................................... 4
2.3. Rocket CRAFT™ Suction Pump .............................................................................................................................................. 5
2.4. Rocket CRAFT™ Suction Pump – Internal View ...................................................................................................................... 6
3. GENERAL DESCRIPTION: ............................................................................................................................................................. 7
3.1. INDICATIONS: ......................................................................................................................................................................... 7
3.2. CONTRAINDICATIONS: .......................................................................................................................................................... 7
3.3. REFERENCES: ........................................................................................................................................................................ 7
4. GENERAL INFORMATION ............................................................................................................................................................. 8
4.1. COPYRIGHT ............................................................................................................................................................................ 8
4.2. MODEL NUMBERS: ................................................................................................................................................................. 8
4.3. MANUAL REVISION: ............................................................................................................................................................... 8
4.4. MANUFACTURER: .................................................................................................................................................................. 8
4.5. SERVICE AGENTS: ................................................................................................................................................................. 8
4.6. SUPPLY VOLTAGE SELECTION ............................................................................................................................................ 9
4.7. ELECTROMAGNETIC COMPATIBILITY ................................................................................................................................. 9
4.8. PACKAGING ............................................................................................................................................................................ 9
4.9. POSITIONING and PLACEMENT of the DEVICE .................................................................................................................... 9
4.10. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS. ......................................................................................... 10
4.11. SYMBOLS USED ON R57685 PATIENT CONNECTION SET. ........................................................................................... 10
5. GENERAL INFORMATION: .......................................................................................................................................................... 11
5.1. General Description: ............................................................................................................................................................... 11
5.2. Indications: ............................................................................................................................................................................. 11
5.3. Contraindications: ................................................................................................................................................................... 11
5.4. References: ............................................................................................................................................................................ 11
6. ANNUAL SERVICE ....................................................................................................................................................................... 12
6.1 Replacing the filter element ..................................................................................................................................................... 12
6.2
Replacing the pump valve & diaphragm set ..................................................................................................................... 14
6.3
Reassembling the valve set ............................................................................................................................................. 17
7. REPAIRS & REPLACEMENTS ..................................................................................................................................................... 19
7.1
Replacing the DUO-VAC Footswitch Connectors ............................................................................................................ 19
7.2
Replacing the gauge in DUO-VAC & Suction Pump models: ........................................................................................... 20
8. FINAL TESTING: ........................................................................................................................................................................... 21
9. FUSE REPLACEMENT: ................................................................................................................................................................ 22
10. CLEANING THE PUMP CASING ................................................................................................................................................ 23
11. YEAR OF MANUFACTURE: ....................................................................................................................................................... 23
12. RETURNING THE PUMP FOR FACTORY REPAIR OR SERVICE: ........................................................................................... 23
13. STORAGE: .................................................................................................................................................................................. 24
14. TRANSPORTATION: .................................................................................................................................................................. 24
15. WARRANTY ................................................................................................................................................................................ 25
16. TECHNICAL SPECIFICATIONS ................................................................................................................................................. 26
16.1. CLASSIFICATION ................................................................................................................................................................ 26
16.2. SPECIFICATIONS................................................................................................................................................................ 26
17. DRAWINGS ................................................................................................................................................................................. 27
17.1. GENERAL ASSEMBLY: ....................................................................................................................................................... 27
17.2. GENERAL ELECTRICAL: .................................................................................................................................................... 28
17.3. GENERAL INSTALLATION: ................................................................................................................................................. 29
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2. GENERAL ASSEMBLY
2.1.Rocket CRAFT™ DUO-VAC Suction Pump
Rocket Craft DUOVAC Pump with footswitch supplied after 2013
1. Illuminated O/I Mains Power On/Off
2. Vacuum Control Dial – clockwise to increase, anticlockwise to decrease the set value
3. Vacuum Display mmHg-1
4. Footswitch connection ports
5. Water trap connection port – recommended for use with R57685 Rocket Craft Pump Water Trap Sets
6. Water Trap Set comprising glass bottle, bung, angled connectors, silicone tube set.
Recommended for use with R57685 Rocket Craft Pump Water Trap Sets
7. Silicone tube set with metal luer connector
8. Footswitch: BLACK: Standard: 50-250mmHg-1 and WHITE: High Vacuum 440mmHg-1 foot-switch
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2.2.Rocket CRAFT™ DUO-VAC Suction Pump – Internal View
1. Vacuum gauge 0-700mmHg – normal range 50-440mmHg-1
2. Illuminated O/I Mains Power On/Off
3. Motor 220VAC 50Hz, 110VAC 60Hz – model dependant
4. Vacuum outlet port
5. Pump head including valve housing
6. Internal silencer with filter chamber
7. Main power input
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2.3.Rocket CRAFT™ Suction Pump
Rocket Craft Suction Pump with earlier metal footswitch.
1. Illuminated O/I Mains Power On/Off
2. Vacuum Display mmHg-1
3. High Vacuum (440mmHg-1) control button
4. Vacuum Control – clockwise to increase, anticlockwise to
decrease the set value
5. Water trap connection port – recommended for use with
R57685 Rocket Craft Pump Water Trap Sets
6. Water Trap Set comprising glass bottle, bung, angled
connectors, silicone tube set.
7. Footswitch connection port
8. Medium Vacuum (Standard) 50-250mmHg-1 footswitch
9. Silicone tube set with metal luer connector
Footswitch supplied on Rocket Craft Suction Pumps
2013 onwards
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2.4.Rocket CRAFT™ Suction Pump – Internal View
1. Vacuum gauge 0-700mmHg – normal range 50-440mmHg-1
2. Illuminated O/I Mains Power On/Off
3. Motor 220VAC 50Hz, 110VAC 60Hz – model dependant
4. Vacuum outlet port
5. Pump head including valve housing
6. Internal silencer with filter chamber
7. Main power input
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3. GENERAL DESCRIPTION:
The Rocket CRAFT™ Oocyte Aspiration Pumps have been developed to provide smooth, low
volume vacuum at a pre-determined negative pressure. Vacuum is activated by a foot operated
toggle air switch controlled by the surgeon performing the oocyte collection.
The range of vacuum is infinitely variable from 10-200mmHg-1 in medium vacuum mode and at a
pre-set 400mmHg-1 in high vacuum mode.
Rocket CRAFT™ Oocyte Aspiration Pumps require either a water trap set (supplied) or R57685
Disposable Rocket CRAFT™ Water Trap Sets, supplied separately, sterile and for single patient
use.
A suitable collection test tube for use with oocyte needle sets is B.D. Falcon test tube No. 2001F,
17 x 100mm.
3.1. INDICATIONS:
For the generation of high vacuum/low volume suction between 10-400 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 gynaecological procedures.
3.2. CONTRAINDICATIONS:
Not intended for use where ovarian aspiration or the aspiration of ovarian fluid is contraindicated.
For short term operation only. The device is NOT intended for continuous drainage.
3.3. 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
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4. GENERAL INFORMATION
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.
4.1. 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 written approval of Rocket Medical plc.
4.2.MODEL NUMBERS:
Rocket Craft™ Suction Pump Complete (110v)
Rocket Craft™ Suction Pump Complete (240v)
R29654
R29655
Rocket Craft™ Duo Vac™ Suction Pump (240v)
Rocket Craft™ Duo Vac™ Suction Pump (110v)
R29660
R29661
This device should only
be used by suitably
qualified personnel.
4.3. MANUAL REVISION:
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
4.4. MANUFACTURER:
Revision 1
Revision 2
Revision 3
Revision 4
Revision 5
Revision 6
Revision 7
First Publication
Addition of drawings
Update of tolerance specifications
Update images with new footswitch
Update to latex statement, symbol
Update to YOM, consumption, footer
Update to LRQA CE mark
15/02/12
29/06/12
23/09/13
30/09/13
06/11/13
16/07/14
27/08/14
Rocket Medical plc
Sedling Road
WASHINGTON
Tyne & Wear
NE38 9BZ
UK.
4.5. SERVICE AGENTS:
CAUTION:
Any adjustment,
modification or repairs
to the equipment
should be carried out
by authorised service
agents.
Rocket Craft™ Pumps typically require only annual maintenance; however it is
recommended they are serviced and calibrated annually at a Rocket Medical plc service
facility.
Failure to service the pump at the indicated intervals may invalidate the Warranty.
Customer Services:
Rocket Medical plc.
Sedling Road. WASHINGTON. NE38 9BZ. ENGLAND
Tel: +44 (0) 191 419 6988. Fax: +44 (0) 191 419 6989
Email: homesales@rocketmedical.com
Disposal of
this device must be
undertaken with regard
to the WEEE directive
(2002/96/EC).
US Office:
Rocket Medical
Unit 1. 150 Recreation Park Drive
HINGHAM. MA 02043. USA
Tel: 1 781 749 6223. Fax: 1 781 749 6235
Email: usa@rocketmedical.com
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4.6. SUPPLY VOLTAGE SELECTION
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
The device operates at a voltage 110V 60Hz or 220-240 VAC @ 50Hz. 0.12A depending
on model.
Ensure that the correct power cord is connected.
4.7.ELECTROMAGNETIC COMPATIBILITY
Rocket Craft Suction Pumps comply with the electromagnetic compatibility (EMC) limits for
medical devices as specified by IEC 60601-1-2:2001. 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.
The device must be operated according to the instructions contained in this manual to
ensure continued electromagnetic compatibility.
4.8.PACKAGING
The packaging has been 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.
WARNING:
ELECTRIC SHOCK
HAZARD.
Do not immerse the
device.
4.9. POSITIONING and PLACEMENT of the DEVICE
Rocket CRAFT™ Oocyte Aspiration Pumps must be placed on a secure, level surface,
away from sources of heat, water splashes, mists or cooling vents. Do not expose to direct
sunlight.
Do not expose to direct sunlight.
Do not expose to flammable gases.
WARNING:
Device can cause
explosion in the
presence of flammable
gases.
Operating temperature Range: +5°C and +35°C
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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual
4.10. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS.
These tables describe their respective meanings.
Mains Power ON/OFF
This device is Type B
CE Mark
4.11. SYMBOLS USED ON R57685
PATIENT CONNECTION SET.
Read the Instruction for Use before connection and use
Device is for Single Use Only
Device is sterilised by Ethylene Oxide
This device is not manufactured with natural rubber latex
CE Mark
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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual
5. GENERAL INFORMATION:
5.1. General Description:
The Rocket CRAFT™ Oocyte Aspiration Pumps have been developed to provide smooth,
low volume/high vacuum at a pre-determined negative pressure. Vacuum is activated by a
foot operated toggle air switch controlled by the surgeon performing the oocyte collection.
The range of vacuum is infinitely variable from 10-200mmHg-1 in medium vacuum mode
and at a pre-set 440mmHg-1 in high vacuum mode.
Rocket CRAFT™ Oocyte Aspiration Pumps require either a water trap set (supplied) or
R57685 Disposable Rocket CRAFT™ Water Trap Sets, supplied separately, sterile and for
single patient use.
A suitable collection test tube for use with oocyte needle sets is B.D. Falcon test tube No.
2001F, 17 x 100mm.
5.2. Indications:
For the generation of low flow/high vacuum between 10-440 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 gynaecological procedures.
5.3. Contraindications:
Not intended for use where ovarian aspiration or the aspiration of ovarian fluid is
contraindicated. For short term operation only. This device is not indicated for continuous
drainage.
5.4. 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
11
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6. ANNUAL SERVICE
6.1 Replacing the filter element
1. Lay the pump on a clean
surface, protecting the
casing from scratches.
WARNING:
ELECTRIC SHOCK
HAZARD.
2. Remove 4 screws from
the casing underside and
retain
3.
Carefully separate the
case halves, ensuring the
front and rear fascia
plates remain located in
the lower shell.
4. Locate filter housing
5. Using fingers, lift the top
away from filter chamber.
CAUTION: Avoid the use of
sharp tools as these may
damage the O’ ring.
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6. Life out the filter
assembly and
remove the filter.
7. Fit new replacement
filter
P/N: E05-000
8. Replace filter,
ensuring the top
seats securely into
the chamber.
9. Avoid trapping or
pinching the ‘O’ ring.
10. Check the top is
correctly seated.
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6.2
Replacing the pump valve & diaphragm set
1. Locate the pump silencer
housing and carefully
remove with a gentle
twisting movement.
2. Using a diagonal method,
remove the 4 screws
securing the pump valve
head.
3. Lift the valve head away
from the pump body to
reveal the pump head
gasket and diaphragm
assembly.
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4. Undo and remove the
centre Pozi drive screw to
release the valve plate.
5. Carefully remove valve
plate from head moulding
with a twisting motion to
separate the two halves
6. Valve gasket and valve
plate.
IMPORTANT
Note the orientation of
the cut-outs on the
valve gasket in relation
to the valve plate.
7. Lift off pump head gasket
and retain safely.
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8. Undo and remove the
centre Pozi drive screw
from the pump diaphragm
retaining plate
9. Retain retaining plate and
screw, discard old
diaphragm
10. Replace diaphragm with
P/N: DO1-053
11. Re-assemble and tighten
sufficient to secure the
retaining plate.
IMPORTANT
DO NOT OVERTIGHTEN
or use excessive force
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6.3
Reassembling the valve set
1. Ensure the valve plates
are orientated as in the
image (right).
VERY
IMPORTANT
IF THIS ORIENTATION IS
REVERSED, THE VALVE
AND PUMP WILL FAIL TO
OPERATE
2. Replace the valve gasket
with P/N: VO1-002
IMPORTANT
Note the orientation of the
cut-outs on the valve gasket
in relation to the valve plate
3. Reassemble the valve
head and tighten the
centre screw
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4. Reseat the pump head
gasket
P/N: GO1-001
5. Replace the valve head
assembly onto the
gasket, ensure the holes
are correctly aligned and
the gasket with seated
correctly.
6. Tighten the valve head
screws in a diagonal
pattern to ensure the
pump head is correctly
seated without distortion.
7.
Re-fit the pump silencer
to the head module.
IMPORTANT
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7.REPAIRS & REPLACEMENTS
7.1
Replacing the DUO-VAC Footswitch Connectors
The front panel connectors of
the DUO-VAC can be subject
to damage through misuse or
repeated over-stressing of the
retaining clips on connection
of the footswitch.
Replacement is a straight
forward operation
1. Remove the upper
casing. (See Section 6)
2. Lift the front panel out of
the retaining grooves on
the lower case
3. Remove tubing by
carefully pulling from
connector.
4. Loosen and remove
securing nut.
5. Replace connector,
locate and tighten
securing nut.
6. Re-fit tubing by pushing
over connector inlet.
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7.2
Replacing the gauge in DUO-VAC & Suction Pump models:
1. Remove the upper
casing. (See Section 6)
2. Lift the front panel out of
the retaining grooves on
the lower case
3. Loosen and remove the
securing nuts or screws
(ringed right).
4. Draw the gauge through
the front panel whilst
supporting the mounting
plate.
5. Detach the gauge from
the centre tube by
carefully pulling the
tubing from the rear
connection.
Rocket Craft DUO-VAC gauge assembly
6. Replace the gauge,
reconnect the centre
tubing and insert through
the front panel.
7. Replace gauge mounting
plate and tighten securing
nuts or screws.
Rocket Craft Suction Pump gauge assembly
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8.FINAL TESTING:
1. Final testing should be
completed with a
validated and
independently calibrated
electronic vacuum gauge
or similar device.
2. Required operating scale:
10-500mmHg in 1mmHg
increments
3. Attach the vacuum test
gauge as indicated in the
image below to the
external vacuum port
4. Attach the footswitch as
for normal operation.
5. Power device on.
6. Occlude the tube to the
test gauge.
7. Activate the Standard
Vacuum footswitch –
observe the green light is
illuminated.
8. Rotate the control knob
clockwise to increase to
the desired value on the
gauge. (See table below)
9. To decrease the value:
rotate anticlockwise.
10. When the desired value is
reached, release the
footswitch and tubing set
occlusion.
WARNING:
Ensure the vacuum
levels are within the
specified accuracy
tolerance before
returning the pump to
clinical service.
11. Activate the Standard
Vacuum footswitch.
12. Record the vacuum
registered.
13. Repeat from #6 for each
of the test values
indicated in the table
(right).
Test
Value
Indicated
vacuum
Test Gauge
50mmHg
100mmHg
200mmHg
Specified accuracy: ±10% of test value
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9.FUSE REPLACEMENT:
WARNING:
ELECTRIC SHOCK
HAZARD.
The equipment is to be
used only with electrical
systems complying with
all IEC, CEC and NEC
requirements.
1. Two 0.5A fuses are
located in the main power
socket mounted on the
rear panel
2. Using a small
screwdriver, carefully
ease out the fuse carrier
to reveal the fuses
3. To ensure continued
protection :
IMPORTANT
REPLACE WITH FUSES
OF IDENTICAL RATING
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10. CLEANING THE PUMP CASING
WARNING:
ELECTRIC SHOCK
HAZARD.
Do not immerse the
device.
At the end of each clinical session, turn off the device at the front panel and disconnect
the device from mains power supply
Using an aqueous solution of 70% alcohol (IMS or isopropyl BP), moisten a cloth and wipe
all external surfaces of the device. If the surface has become contaminated with
proteinaceous material, remove with a light detergent solution before surfacing cleaning
with alcohol.
Do NOT use a 100% alcohol or any other solvent to clean the device as this may cause
damage to the casing surface and display.
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
Prevent any fluid from entering the device.
11. 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.
WARNING: No user
serviceable parts
inside.
12. RETURNING THE PUMP FOR
FACTORY REPAIR OR SERVICE:
All devices to be returned must be prepared as described below for the protection of the
servicing team and for safety during transport.
HAZARD:
Do NOT include used
consumables as these
pose a significant
contamination risk
IMPORTANT
A decontamination
certificate MUST be
included with every
returned pump.
1. Surface clean the pump as described in the Section 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
Repair or servicing
cannot be commenced
unless the service
agent is in possession
of this certificate
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13. STORAGE:
The device must be stored and operated in temperatures +5°C to +35°C
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
14. TRANSPORTATION:
The device must be transported in temperatures +5°C to +35°C
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.
Weight:
Dimensions:
W - 264mm
H - 124mm
D - 164mm
Unit – 1.9Kg
Foot Switch:
o 0.57Kg – DUOVAC (plastic)
o 0.34kg – Craft Suction (plastic)
o 0.51Kg – DUOVAC (metal)
o 0.38kg – Craft Suction (metal)
Protect the device from ingress of liquid. Should any liquid enter the
device, discontinue use immediately and refer to an authorised service
agent
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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual
15. WARRANTY
Rocket CRAFT™ 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.
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Copyright© 2012-14
Rocket Medical plc. .
All rights reserved.
ZDOCK226
Rev:7
27/08/14