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Rocket Medical R54569 Instructions For Use Manual

Portable suction unit
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Portable Suction Unit (PSU) Pumps
ZDOCK324 Rev. 10
Language
en
1639
Rocket, ROCKET, the R device and the Rocket Medical logo are registered trademarks of Rocket Medical Plc.
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 approval of
Rocket Medical plc
Template223 Rev: 08
ROCKET MEDICAL PLC
Sedling Road, Washington,
NE38 9BZ, UK
Australian Sponsor:
Page
ROCKET MEDICAL GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany
ROCKET MEDICAL GmbH
Am Rosengarten 48,
15566 Schöneiche.
Germany
ROCKET MEDICAL LLC
50 Corporate Park Drive #890.
East Pembroke. MA. 02359.
USA
ROCKET MEDICAL PTY LTD
Suite 6, 157 Gordon Street,
Port Macquarie,
NSW 2444. Australia
Page 1 of 41
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  • Page 1 Australian Sponsor: Port Macquarie, NSW 2444. Australia Rocket, ROCKET, the R device and the Rocket Medical logo are registered trademarks of Rocket Medical Plc. 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 approval of...

  • Page 2: Table Of Contents

    Contents SAFETY INSTRUCTIONS ......................... 3 Ultrasound Technologies Ltd ......................... 3 ABOUT THE PSU ..........................5 INTENDED USE ..........................6 INDICATIONS ..........................6 2.4 CONTRAINDICATIONS ........................6 WARNINGS: ............................. 6 2.6 BENEFIT RISK ............................8 2.7 PERFORMANCE CLAIMS AND CLINICAL BENEFIT ................8 2.8 UNDESIRABLE SIDE EFFECTS .......................

  • Page 3: Safety Instructions

    The Rocket R54569 Digital low vacuum/low flow Suction Unit is EMC tested in conformity with the requirements of EN 60601- 1-2:2015 and can be used in the vicinity of other EMC tested devices that fulfil the requirements outlined in the EN 60601-1- 2:2015 standard.
  • Page 4 WARNING Device can cause explosion in the presence of flammable gases In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 5: About The Psu

    Carry Handle On/Off Button Control/Decision interface In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 6: Intended Use

    The R54500 chest drain unit and tubing set (R54502, R54539) are single use parts and their instructions for use must be followed at all times. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 7 Sterile accessories (Filter Unit R54751) packaging must be checked for integrity before use. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 8: Benefit Risk

    No user serviceable parts inside. 2.6 BENEFIT RISK: Rocket Medical plc has taken all necessary steps to ensure that residual risks associated with the use of the Portable Suction Unit are reduced as far as possible through application of existing state of the art techniques in the design and manufacture of these medical devices to ensure safe usage.

  • Page 9: Environment

    GENERAL INFORMATION 3.1 SUPPLY VOLTAGE SELECTION In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 10: Electromagnetic Compatibility

    H - 118mm • D - 140mm In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 11: Essential Consumables

    The PSU can be operated from the mains power supply or with the inbuilt battery (Rechargeable Lithium-Ion 14.4V nominal, capacity approx. 2250mAh – Type 4SP1 4 cell 34Wh). In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 12: Symbols And Safety Signs Used On The Device And Labelling

    PSU does not run continuously but only switches on when the actual and nominal values differ. During continuous battery operation, Rocket Medical guarantees a minimum run time of 4 hours, after the battery has been fully charged.
  • Page 13 18V DC connection polarity Warning In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 14: Operating Instructions

    It is protected, and is behind the door marked Charge the device for approximately 3 hrs until the battery display is full. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 15 When the self-test has completed, follow the software instructions to set the time and date In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 16 The suction unit must be cleaned and disinfected between patient use, according to the Rocket cleaning guidelines. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 17 Ensure when placing the filter, the location peg is placed in the aperture which the green venting cap was in. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com...
  • Page 18 Place the PSU on to the chest drain unit. With slight downward pressure rotate the locking ring Anti-clockwise so that it locks into position. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 19 Bottle is now ready for disposal. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 20 No – Patient number is unchanged: Recommended for continued treatment of the same patient. Data recording is continued. – Follow column B. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 21 In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 22 In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 23 When the suction unit is in situ and suction is applied 4 different display modes are available to view. Scroll through the 4 screens by pressing button number 1. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 24 This screen shows the previous 1 minute of use. Flow is measured from 0.5L/min (screen not shown). In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 25 The PSU will continue at the programmed suction level. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 26: Options Menu

    Dutch Use the Exit option to leave the options screen. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 27: Switching The Unit Off

    The error number corresponds to the problem as shown below. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 28 Please charge battery In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 29 Filter needs changing Change filter In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 30 If a reset of the PSU is required, disconnect from the power supply and then press the reset button. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 31: Device Cleaning

    Do not immerse the device. WARNING: Do NOT attempt to sterilise the device In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 32: Data Retrieval

    You will be able to save patient data into an identifiable record using the “save as” function. Click on - Connect Device In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 33 The device will store the information of up to 10 patients. When the storage is full, then the oldest patient record or information is automatically deleted. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 34 The blue line indicates flow (size of air leak). The green line indicates pressure applied (suction). In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 35 Device Stats provides information for use during servicing. WARNING: Data retrieval should not take place while the PSU is in use. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 36: Service

    In the unlikely event that the lithium battery is showing signs of leakage the PSU must be immediately taken out of service, the battery must be disconnected from the main PCB and the service engineer must contact Rocket Medical for advice as to how to proceed.

  • Page 37: Emc Tables

    In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 38 Note: Ut is the a.c. mains voltage prior to application of the test level. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.
  • Page 39 PSU device. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. In the event a serious incident related to this device occurs, the event should be reported to Rocket Medical at pncf@rocketmedical.com well as to the competent health authority in the country that the user/patient resides.

  • Page 40: Warranty

    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.

  • Page 41: Disposal

    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...

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