RocketCraft Oocyte Aspiration Pumps Service Manual Rev 7 Aug 2014

Service Manual

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File Size: 7.82 MB

File Name: rocketcraft_oocyte_aspiration_pumps_service_manual_.pdf

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SERVICE MANUAL Rocket CRAFT™ Oocyte Aspiration Pumps

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

Rocket Medical plc. .

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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

2.4.Rocket CRAFT™ Suction Pump – Internal View

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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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

Rocket Medical plc. .

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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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: [email protected]

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: [email protected]

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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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

Rocket Medical plc. .

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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

Rocket Medical plc. .

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Rev:7

27/08/14

Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

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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