Rocket Medical CRAFT Operator's Manual
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Rocket Medical CRAFT Operator's Manual

Oocyte aspiration pumps
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OPERATORS GUIDE
Rocket
®
CRAFT™
and
DUOVAC™
Oocyte Aspiration Pumps

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Summary of Contents for Rocket Medical CRAFT

  • Page 1 OPERATORS GUIDE Rocket ® CRAFT™ DUOVAC™ Oocyte Aspiration Pumps...

  • Page 2: Table Of Contents

    POSITIONING and PLACEMENT of the DEVICE .................... 8 4.8. WARNINGS ............................... 9 4.9. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS ............... 10 4.10. SYMBOLS USED ON R57685 SINGE USE WATER TRAP ................11 5. GENERAL INFORMATION: ............................12 5.1. GENERAL DESCRIPTION: ..........................12 5.2.

  • Page 3: General Assembly

    2. Vacuum Control Dial – clockwise to increase, anticlockwise to decrease the set value 3. Vacuum Display mmHg 4. Footswitch connection ports 5. Water trap connection port for use with R57685 Rocket Craft Pump Water Trap Sets 6. R57685 Rocket Craft Pump Water Trap Set 7. Medium Vacuum (Standard) 50-250mmHg &...

  • Page 4: Rocket Craft™ Suction Pump

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 2.2. Rocket CRAFT™ Suction Pump 1. Illuminated O/I Mains Power On/Off 2. Vacuum Display mmHg 3. High Vacuum (440mmHg-1) control button 4. Vacuum Control – clockwise to increase, anticlockwise to decrease the set value 5.

  • Page 5: General Instructions

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 3. GENERAL INSTRUCTIONS 3.1. COPYRIGHT WARNING: READ THIS MANUAL This manual contains information that is subject to copyright. All rights reserved. CAREFULLY: Please This manual should not be photocopied, duplicated or distributed completely or in part...

  • Page 6: Manufacturer

    NE38 9BZUK. 3.5. SERVICE AGENTS: Rocket Craft™ Pumps typically require little routine maintenance; however they must be 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.

  • Page 7: Safety Instructions

    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. The device must be used with R57685 Rocket CRAFT™ Water Trap (Patient Connection) WARNING: Protect the device from Sets.

  • Page 8: User Training

    IEC, CEC and NEC requirements. Contact your local Rocket Medical sales office or distributor for further training support. See our website www.rocketmedical.com for details of your local office End User Training includes: 1.

  • Page 9: Warnings

    The Rocket Craft Pump 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..

  • Page 10: Symbols Used On Craft Suction & Duo-Vac Pumps

    4.9. SYMBOLS USED ON CRAFT SUCTION & DUO-VAC PUMPS. These tables describe their respective meanings. Mains Power ON/OFF This device is Type B Footswitch connection port Dispose of this device in accordance with WEEE directive (2002/96/EC) Earthed Read the manual before connection and use...

  • Page 11: Symbols Used On R57685 Singe Use Water Trap

    Device is for Single Use Only Device is sterilised by Ethylene Oxide The device is not manufactured with natural rube latex Do not use if pack is opened or damaged CE Mark Rev: 32 2020-08-19 Copyright© 1991-2020 Rocket Medical plc . All rights reserved. ZDOCK105...

  • Page 12: General Information

    For short term operation only. NOT 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.’...

  • Page 13: Operating The Pump

    6. OPERATING THE PUMP WARNING: Rocket CRAFT™ Suction Pump: This device must only be operated with 1. Unwrap the footswitch and attach approved consumables. the air tubing to the ports on the front of the pump casing. The footswitch is normally left...
  • Page 14 IEC, CEC and NEC requirements. 3. Using aseptic technique, un-pack the R57685 Rocket CRAFT™ Water Trap Set and attach the short tubing length to the water trap connection point 4. Pass the longer patient connection tube into the operative field.
  • Page 15 440mmHg-1. Rocket CRAFT™ Suction Pump 14. To activate the HIGH vacuum, occlude the RED button and depress the footswitch – the pump will immediately deliver a vacuum of 440mmHg 15.
  • Page 16 Rev: 32 2020-08-19 Copyright© 1991-2020 Rocket Medical plc . All rights reserved. ZDOCK105...

  • Page 17: Procedure

    6.2. 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.

  • Page 18: Consumables

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 7. CONSUMABLES R57685 Rocket CRAFT™ Water Trap WARNING: (Patient Connection) Set This device must only glass water trap bottle 2.5m patient connection tube be operated with with male luer connector. Supplied sterile, for single approved consumables use in cartons 10 units.

  • Page 19: Cleaning The Pump Casing

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 8. CLEANING THE PUMP CASING At the end of each clinical session, turn off the device at the front panel and disconnect the device from mains power supply WARNING: Using an aqueous solution of 70% alcohol (IMS or isopropyl BP), moisten a cloth and wipe ELECTRIC SHOCK all external surfaces of the device.

  • Page 20: Storage & Transportation

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 11. 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...

  • Page 21: Operating Environment

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 12. OPERATING ENVIRONMENT: The device must be transported in temperatures +5°C to +35°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.

  • Page 22: 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.

  • Page 23: Technical Specifications

    Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide 15. TECHNICAL SPECIFICATIONS 15.1.CLASSIFICATION IEC 60601-1 Type of protection against electric shock: Class I 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.

  • Page 24: Emc Tables

    Table 2: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity: Rocket Craft Aspiration Pumps (the device) is intended for use within the electromagnetic environment specified below. The operator of a device should ensure that it is used within such an environment.
  • Page 25 Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The device is intended for use within the electromagnetic environment specified below. The customer or the operator of a should ensure that it is used within such an environment.
  • Page 26 Rocket CRAFT™ Oocyte Aspiration Pumps – Operators Guide Table 4: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Rocket Oocyte Aspiration Pump. The device is intended for use in the electromagnetic environment specified below. The operator of the device can help prevent electromagnetic interference by maintaining a...

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