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HK KTIP Instruction Manual

Klein tumescent infiltration pump
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HK Klein Tumescent Infiltration Pump
Instruction Manual
Manual Version: C
Date of Issue: 2.16.2023
We reserve the right to make changes in the course of technical development without previous notice.
© 2021 HK Surgical Inc. All rights reserved.
1271 Puerta del Sol
San Clemente, CA 92673
USA
Neither this manual nor any parts of it may be duplicated or transmitted in any way without the
written approval of HK Surgical Inc.
UMKTIP Domestic Doc. 500154 Rev C
- Instruction for Use -

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  • Page 1 Manual Version: C Date of Issue: 2.16.2023 We reserve the right to make changes in the course of technical development without previous notice. © 2021 HK Surgical Inc. All rights reserved. 1271 Puerta del Sol San Clemente, CA 92673 Neither this manual nor any parts of it may be duplicated or transmitted in any way without the written approval of HK Surgical Inc.

  • Page 2: Liability Statement

    Subsequent guides may be changed without prior notice; however, HK Surgical assumes no liability for harm caused directly or indirectly by errors from the guide. The HK Klein Tumescent Infiltration Pump (HK KTIP) is a medical device that will be used by medical professional only.
  • Page 3 This manual provides instruction for operation and troubleshooting procedures and will help you with all the applications and enable you to use all functions of the HK KTIP. If you have any questions that are not answered in this user guide, our HK KTIP team will be happy to help you.

  • Page 4: Table Of Contents

    Contents Contents INTRODUCTION............................4 1.1..........................4 ERMS AND EFINITIONS 1.2............................5 ANUFACTURER 1.3......................5 DENTIFICATION OF THE NSTRUMENT 1.4..............................5 EPAIR 1.5..............................6 ARRANTY 1.6..........................6 RDERING INFORMATION 1.7............................ 6 ETURN ROCEDURE SAFE HANDLING ............................7 2.1.

  • Page 5: Introduction

    1. Introduction This manual describes the use of the HK Klein Tumescent Infiltration Pump in surgical settings with trained personnel. The following pages of this manual will guide you through the proper usage of the HK KTIP instrument. 1.1. Terms and Definitions Here is a description of the terms and symbols used in this guide and on the instrument.

  • Page 6: Manufacturer

    1271 Puerta del Sol San Clemente, CA 92673, USA 1.3. Identification of the Instrument Identification label is placed at the back panel of the HK Klein Tumescent Infiltration Pump. Figure 1 Identification label details placed on the back panel of the instrument.

  • Page 7: Warranty

    HK Surgical products are warranted to be free from manufacturing defects in materials and workmanship for a period of one year from date of purchase. HK Surgical will repair or replace, free of charge, any part, or parts that are defective in material or workmanship during that time period.

  • Page 8: Safe Handling

    2.2. Intended Use The HK Klein Tumescent Infiltration Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.

  • Page 9: Statutory Requirements

    Make sure the electrical and environmental conditions are met described in Section 7. In addition, HK Surgical clearly states that using the instrument in a manner not specified by this manual or by HK Surgical elsewhere may affect the protection supported by the instrument and may result in a hazardous situation.

  • Page 10: Environmental/Operational Conditions

    If you have any questions or doubts concerning the compatibility of cleaning and disinfection solutions with instrument components or component materials, please contact HK Surgical. Before cleaning and disinfecting the instrument, disconnect the instrument from the power supply (pull the plug). The operator is solely responsible for the effectiveness of the disinfection methods used.
  • Page 11 Use of this equipment immediately adjacent to other equipment or with other equipment in a stacked configuration should be avoided as it may result in improper operation. If use in the manner described above is nevertheless necessary, this instrument and the other instruments should be observed to satisfy themselves that they are operating properly.

  • Page 12: Safety Symbols/Warning Or Other Labels On The Instrument

    These cautions and warnings are considered essential to the safety of personnel, patients, equipment, and property. If you have any questions, please contact HK Surgical. Table 1 - Safety Symbols/Warning or other Labels on the Instrument.

  • Page 13: Delivery/Disposal

    The infiltration fluid, tubing and spike, spinal needles and cannulas are required for operation but not included in the delivery and must be ordered separately. These accessories can be purchased from HK Surgical, if you need assistance, please contact HK Surgical at 800-909- 0060.

  • Page 14: Disposal

    In the European Union, disposal of the instrument is regulated by Directive 2012/19/EU on waste electrical and electronic equipment (WEEE), and corresponding national transpositions. HK Surgical is committed to taking back and recycling electrical and electronic equipment in areas where the above-mentioned directive is enforced.

  • Page 15: Operating

    4. Operating 4.1. Description of the Instrument Pump Head 2x ports Membrane Keypad for foot switch Figure 1 Front Side of the Instrument Fixation for Power Supply Figure 2 Rear Side of the Instrument Power Port Figure 3 24VDC Power Port Connector UMKTIP Domestic Doc.

  • Page 16: Setup Instructions

    Pneumatic Footswitch 4.2. Setup Instructions The HK Klein Tumescent Infiltration Pump is intended for indoor use only and should be operated in a room with a controlled temperature. Before the instrument is powered on ensure that the instrument is at room temperature. Make sure that the electrical and environmental conditions are met (see Section 7).
  • Page 17 Power Supply 2. , 4 and 5). 3. Attach the power supply to Fixation for Power Supply using the two pieces of Velcro. (see Table 2). 4. Connect Pneumatic Footswitch(s) to Port(s) on front side of instrument. 5. The infiltration fluid, tubing and spike, spinal needle or cannula must be sterile. 6.
  • Page 18 b............... Take the power supply block and place it onto the brackets as shown. Ensure the power supply block remains rested on the blocks ledges while installing the velcro straps. Take the lower end of the left velcro strap and loop it over the power supply block until the strap end covers the whole power supply block as shown.
  • Page 19 Do not switch on the device if there is visible damage. In this case, contact HK Surgical. The entry for the power supply is marked with a label. The user must ensure that 24V DC the voltage of the power supply matches the voltage shown on the label.
  • Page 20 Diameter - Silicone Sleeve Section (ID x OD) = .187in x .375in Sterilization Process: Sterilized using ethylene oxide. Figure 3 Single Spike Infiltration Tubing (ITS) Product Name: HK CV Single Spike Infiltration Tubing (CVT) Manufacturer: HK Surgical Length: 200in (508cm) Diameter - Subcutaneous Infiltration Tubing Section (ID x OD) = .110in x .160in...
  • Page 21 HK CV Single Spike Infiltration Tubing (CVT) Product Name: Double Spike Infiltration Tubing (ITD) Manufacturer: HK Surgical Length: 201.5in (512cm) Diameter - Subcutaneous Infiltration Tubing Section (ID x OD) = .110in x .160in Diameter - Silicone Sleeve Section (ID x OD) = .187in x .375in...
  • Page 22 9. Place tubing on roller section ensuring the tubing is inserted correctly and in the appropriate direction and that the flow of fluid is from left to right, as shown by the arrow applied to the pump head (see Figure 6). When facing the instrument, the spike end of the tubing is on the left side and the luer lock end of the tubing set leading to the patient is on the right side.
  • Page 23 10. Lower pump head lid to the down (closed) position and lock in place. Figure 8 Closing the Pump Head Connect pneumatic foot switch tubing to ports located on the front of the HK KTIP, under the pump head (see 11. Figure 9).
  • Page 24 Figure 9 Pneumatic Footswitch Connectors The pneumatic connectors are marked with a label. To ensure the correct connection between the footswitch and the instrument, there is a click connection where a click is heard when the connector is correctly engaged. 12.

  • Page 25: Instrument Operating Procedures

    4.3. Instrument Operating Procedures If the installation instructions from section 4.2 have been executed, the device can now be operated via the membrane keypad (see Figure 10). On the membrane keypad, the pump motor can be controlled via the Start and Stop key as well as via the foot switch. One or two pneumatic foot switches can be used to switch the pump motor on and off.
  • Page 26 4.3.1. Power Mode When neither the green light nor the red light is on, the HK Klein Tumescent Infiltration Pump is not receiving electric power from a wall outlet. A red light will indicate that the HK Klein Tumescent Infiltration Pump is connected to a wall outlet and is receiving electric power but is in Stand-By Mode.
  • Page 27 4.3.3. Running the pump motor To start the pump motor, press the Start Key. In Toggle mode, the pump motor starts when the Start button is pressed once START briefly and runs until the Stop button is pressed. In Pressure Mode, the pump motor will run as long as the Start key is pressed. As feedback for the user whether the pump is currently running, there is a visual indication in the form of a green flashing LED of the START key.
  • Page 28 To stop the pump motor, press the Stop Key. This only applies to toggle mode. In pressure mode, simply release the Start key or release foot from foot pedal to stop the pump motor. If the pump is not in operation, the green LED is switched off and the red LED of the STOP key lights continuously.
  • Page 29 Note: The Klein Tumescent Infiltration Pump® is suitable for permanent use up to a speed of 400 RPM or up to 600 RPM for short periods. Spinal needles with diameter smaller than 0.047in (1.2mm) should be used at pump speeds up to max 400 RPM as they do not deliver significantly higher volume rates above 400 RPM.

  • Page 30: Cleaning/Maintenance

    By following the preparatory and follow-up work instructions for the system, you will keep the instrument in good shape and significantly prolong its working life. If your instrument malfunctions, please contact HK Surgical. 5.1. Cleaning the System To clean the outer surfaces of the instrument wear gloves. Dirt, stains, and dried materials can be removed from the case by using any mild nonabrasive cleanser.

  • Page 31: Repairs

    It is not allowed to open the instrument and access the inner part of the instrument. PLEASE NOTE In case of a requested return of the instrument to HK Surgical, only cleaned, and disinfected instruments are accepted. 5.3. User Maintenance NO PUMP MAINTENANCE IS REQUIRED.

  • Page 32: Troubleshooting

    6. Troubleshooting Please contact HK Surgical for assistance if the following solutions do not resolve the problem. PROBLEM POSSIBLE CAUSES SOLUTION Pump not operating 1. Instrument not powered on 1. Press Power key. (Power LED “off” or “red”). 2. Plug power cord into outlet.

  • Page 33: Technical Specification

    7. Technical Specification Item Specification Rated Speed Range 0 – 600 RPM Up to 1000 mL/min depending on pump speed and canular Flow rate selected Mode of operation Toggled or Pressure Leakage Current within IEC 60601-1 Dimensions (DxWxH) 12 ” x 9 ” x 6 ”/ 31 cm x 23 cm x 15 cm Weight 11 lbs.

  • Page 34: Emc Specification

    Medical electrical equipment is subject to special precautions with respect to EMC and the HK Klein Tumescent Infiltration Pump® is intended for operation in the electromagnetic environment specified below. The user of the HK Klein Tumescent Infiltration Pump® should ensure that it is used in such an environment.
  • Page 35 Test Frequency Service Modulation Immunity Frequency Band Test Level [MHz] [MHz] [V/m] Pulsmodulation 380 - 390 TETRA 400 18 Hz GMRS 460, 430 - 470 ± 5 kHz Hub FRS 460 1 kHz Sinus Pulsmodulation 704 - 787 LTE Band 13, 17 217 Hz GSM 800/900, TETRA 800,...

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