Rocket Digital Oocyte Aspiration Pump Service Manual Rev 3 July 2015

Service Manual

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File Name: rocket_digital_oocyte_aspiration_pump_service_manua.pdf

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Page 1

SERVICE MANUAL Rocket Digital Oocyte Aspiration Pump

Rocket CRAFT™ Oocyte Aspiration Pumps – Service Manual

1. CONTENTS 1. CONTENTS... 2 2. GENERAL ASSEMBLY... 3 2.1.

Rocket Digital Oocyte Aspiration Pump ... 3

2.2.

Rocket Digital Oocyte Aspiration Pump – Internal View ... 4

3. GENERAL DESCRIPTION: ... 5 3.1. INDICATIONS: ... 5 3.2. CONTRAINDICATIONS: ... 5 3.3. CLASSIFICATION ... 5 3.4. REFERENCES: ... 5 4. GENERAL INFORMATION ... 6 4.1. COPYRIGHT ... 6 4.2. MODEL NUMBER: ... 6 4.3. MANUAL REVISION: ... 6 4.4. MANUFACTURER: ... 6 4.5. SERVICE AGENTS: ... 6 4.6. SUPPLY VOLTAGE SELECTION ... 7 4.7. ELECTROMAGNETIC COMPATIBILITY ... 7 4.8. PACKAGING ... 7 4.9. POSITIONING and PLACEMENT of the DEVICE ... 7 4.9. SYMBOLS USED ON OOCYTE ASPIRATION PUMP. ... 8 4.10. SYMBOLS USED ON POWER SUPPLY UNIT. ... 9 4.11. SYMBOLS USED ON R57686 PATIENT CONNECTION SET. ... 9 5. ANNUAL SERVICE ... 10 5.1

Replacing the inlet and exhaust filters ... 10

5.2

Replacing the pump valve & diaphragm set ... 12

5.3

Reassembling the chassis into the casing ... 15

6. POST SERVICE INSPECTION... 17 6.1 RESET Pump Timer to ZERO ... 21 7. CLEANING THE PUMP CASING ... 22 8. YEAR OF MANUFACTURE: ... 22 9. RETURNING THE PUMP FOR FACTORY REPAIR OR SERVICE: ... 22 10. STORAGE: ... 23 11. TRANSPORTATION: ... 23 12. WARRANTY ... 24 13. DISPOSAL: ... 24 14. TECHNICAL SPECIFICATIONS ... 25 14.1. CLASSIFICATION ... 25 14.2. SPECIFICATIONS ... 25 15. DRAWINGS... 26 15.1. Set-up Flow Chart ... 26

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2. GENERAL ASSEMBLY 2.1.

Rocket Digital Oocyte Aspiration Pump

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 -1

6. User Set Suction Indicator LED (Blue,50-300mmHg ) -1

7. Pre-set (Max) Suction Indicator LED (Orange, 500mmHg ) 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.

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2.2.

Rocket Digital Oocyte Aspiration Pump – Internal View

1. O/I Mains Power On/Off 2. Vacuum display 0-500mmHg

-1

– normal range 50-300mmHg

-1

3. Motor 12V 4. Pump head including valve housing 5. Vacuum outlet port 6. Vacuum inlet filter 7. Vacuum control solenoid 8. Internal silencer with filter chamber (A) 9. Internal silencer with filter chamber (B) 10. Internal exhaust vent and filter 11. Control PCB with ribbon cable to vacuum control touch wheel

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3. 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. -1

-1

The range of suction is variable from 50-300mmHg and at a pre-set 500mmHg in ‘Max’ suction mode. The Rocket Oocyte Aspiration Pump requires a disposable filter set for attachment of the pump to the oocyte collection needle. The filter set is supplied separately, sterile and for single patient use. You will also require:   

A suitable oocyte aspiration needle such as Rocket SX Single Lumen Oocyte Aspiration Set (R57602-00-90) Suitable collection tubes for use with oocyte needle sets such as B.D. Falcon test tube No. 2001F, 17 x 100mm. Flushing media

3.1. INDICATIONS: -1

For the generation of high vacuum/low volume suction between 50-500 mmHg 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.CLASSIFICATION 

IEC 60601-1: 2005



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

3.4. 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

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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. This device should only be used by suitably qualified personnel.

WARNING: ELECTRIC SHOCK HAZARD. The equipment is to be used only with electrical systems complying with all IEC, CEC and NEC requirements.

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 NUMBER: Rocket Digital Suction Pump Complete (110v)

R29700

Power supply:

MPU30B-3

4.3. MANUAL REVISION: Revision 1 Revision 2 Revision 3

First Publication Update of LRQA CE mark Pump timer zero procedure

05/11/13 27/08/14 15/07/15

4.4. MANUFACTURER: 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 Digital Pumps typically require only annual maintenance; however it is recommended they are serviced and calibrated annually at a Rocket Medical plc approved 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).

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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 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. The device operates at a voltage 110V 60Hz or 220-240 VAC @ 50Hz. 0.12A

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 WARNING: ELECTRIC SHOCK HAZARD. Do not immerse the device.

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.

4.9. POSITIONING and PLACEMENT of the DEVICE WARNING: Device can cause explosion in the presence of flammable gases.

Rocket Digital 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 flammable gases. Operating temperature Range: +5°C and +35°C

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4.9. 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

This device is powered by a Class II power supply unit.

Indicates the Service Interval Indicator

Suction Display Touch control symbol.

-1

Indicates activation of the pre-set (Max) 500mmHg mode

-1

Indicates activation of the user set 50-300mmHg mode

Dispose of this device in accordance with WEEE directive (2002/96/EC)

CE Mark

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4.10. 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

4.11. 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

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5. ANNUAL SERVICE 5.1

Replacing the inlet and exhaust filters

1. Lay the pump on a clean surface, protecting the casing from scratches. WARNING: Observe precautions for handling electrostatic discharge sensitive devices

2. Remove 3 screws from the rear casing and retain

3. Turn the pump over and remove 3 screws from the front lower casing and retain

4. Remove white silicone retaining ‘O’ ring from vacuum inlet port 5. CAUTION: Avoid the use of sharp tools as these may damage the O’ ring.

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6. Detach ribbon cable from the front panel vacuum controller PCB by lifting the tab

7. Carefully detach the ribbon from the front cover and store securely.

8. Detach patient outlet filter from tube 9. Unclip filter from spring clip, discard and replace filter.

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5.2

Replacing the pump valve & diaphragm set

9. Unscrew two securing nuts and lift out chassis to gain access to pump head. 10. Angle chassis to support on casing

11. Unscrew 4 screws form the pump head in a crosswise manner to prevent distortion of the pump head

12. Discard and replace the pump head/valve module

IMPORTANT

13. CAREFULLY remove the diaphragm by unscrewing the centre screw (arrowed)

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14. Remove the diaphragm to reveal the piston head. 15. Ensure the piston is free to move and that there is no contamination or corrosion evident.

16. Discard old diaphragm and replace. 17. Centralise piston into housing and re-attach diaphragm, plate and screw. DO NOT OVERTIGHTEN SCREW IMPORTANT

IMPORTANT: Note valve head orientation 18. Discard old head gasket and replace with new component. IMPORTANT

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19. Re-attach inlet vacuum tubing to TOP port 20. Re-attach exhaust filter to BOTTOM port. 21. Relocate exhaust filter in bottom of case

22. Tighten screws in a crosswise fashion to avoid distorting the pump head. IMPORTANT

DO NOT OVER TIGHTEN

23. Return chassis into casing 24. Re-tighten two securing nuts.

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5.3

VERY IMPORTANT

Reassembling the chassis into the casing

25. Pass patient outlet filter underneath tubing and re- attach filter to patient connection port tube.

26. Re-clip filter into spring clip 27. Ensure tubing is not trapped by spring clip and correctly routed to avoid occlusion

28. Re-attach ribbon cable from PCB to the front panel vacuum controller PCB by lifting the tab 29. Carefully inserting the ribbon and closing the tab securely.

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30. Lay the pump on a clean surface, protecting the casing from scratches.

IMPORTANT DO NOT OVER TIGHTEN THE SCREWS

31. After re-assembling the upper casing to the lower frame, re-install 3 screws to the rear casing

32. Turn the pump over and re-install 3 screws to the front lower casing.

CAUTION: Avoid the use of sharp tools as these may damage the O’ ring.

33. Re-install the white silicone retaining ‘O’ ring to the vacuum inlet port.

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6. POST SERVICE INSPECTION 1. Attach 240V Main cable to 12V Power Supply Unit (PSU) Model number: MPU30B-3 and connect to an electrical supply 240VAC 50Hz. The power supply module is self-regulating to generate 12VDC 2. Attach 12V lead to rear input port on the Rocket Digital Oocyte Aspiration Pump (RDOAP)

3. Attach the footswitch air tubing to the male/female ports on the underside of the pump casing. 4. CHECK for security of attachment

5. .Turn the power switch 0-I  (rear panel) to on 6. CHECK: The green power LED (indicated) on the front panel is illuminated. 7. The main display will display an -1 initial value of 100mmHg

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8. CHECK the main display holds a steady -1 value of 100mmHg

On Start-Up, the pump is pre-set to 100mmHg suction

-1

9. Place a finger on the control surface and using a rotating motion: The central blue dot is NOT active. 10. CHECK to see the display changes in 5 (-mmHg) increments down to 50mmHg and up to a maximum of 300 (-mmHg) 11. CHECK the active dial zone will sense the clockwise motion to increase the display in -1 5mmHg increments. 12. CHECK using an anticlockwise circular motion to decrease the value.

13. CHECK that a value of 150-mmHg can be set by selecting the value and holding the finger still for 2 seconds when an audible ‘beep’ will confirm the new setting.

14. CHECK: If the new setting is not correctly saved, the value will return to its previous set value in 5-10 seconds’

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The footswitch control operates on a toggle switch, press once for ON and depress again for OFF 15. Depress the WHITE a pedal once. 16. CHECK: The warning tone sounds to indicate activation of the footswitch.

17. CHECK that the blue LED has illuminated and is flashing rapidly to confirm suction is active. 18. Stop the suction by depressing WHITE pedal once again. 19. CHECK the pump stops immediately and the blue LED has gone out.

Repeat the process for HIGH Vacuum 20. Depress the BLACK pedal once. 21. CHECK: The warning tone sounds to indicate activation of the footswitch 22. CHECK that the blue LED has illuminated and is flashing rapidly to confirm suction is active. 23. CHECK that the ORANGE LED (arrowed right) has also illuminated to confirm HIGH Vacuum is now active. 24. CHECK that the display indicates 500 -1 mmHg 25. Stop the suction by depressing BLACK pedal once again. 26. CHECK the pump stops immediately and the blue LED has gone out.

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27. Connect a calibrated vacuum test gauge to the patient port on the pump

WARNING: Ensure the vacuum levels are within the specified accuracy tolerance before returning the pump to clinical service.

28. RECORD the Test Gauge serial number and calibration date in the table below

29. Set the pump display to each of the indicated values on the table in turn. 30. Activate the WHITE, low vacuum pedal for the lower values and the BLACK pedal for the Max vacuum value

Test Gauge

31. RECORD: the values on the gauge in the table below

Calibration Date

Serial Number

32. Acceptance criteria: ± 10% of displayed value

Display Value -1 mmHg 100mmHg

-1

VACUUM BLEED TEST 150mmHg

Confirm bleed to 0mmHg in <2.0 seconds

-1

VACUUM BLEED TEST 200mmHg

INITIAL TO CONFIRM COMPLETED

Recorded Value

Confirm bleed to 0mmHg in <2.0 seconds

-1

VACUUM BLEED TEST

Confirm bleed to 0mmHg in <2.0 seconds

MAX -1 500mmHg VACUUM BLEED TEST

Confirm bleed to 0mmHg in <2.0 seconds

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