Carilex VT-100 Instructions For Use Manual

Negative pressure wound therapy
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Carilex® VT・100
Negative Pressure Wound Therapy
Instructions for Use
U-2S1001-30161 V1.6 Page 1 of 23

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Summary of Contents for Carilex VT-100

  • Page 1 Carilex® VT・100 Negative Pressure Wound Therapy Instructions for Use U-2S1001-30161 V1.6 Page 1 of 23...
  • Page 2: Table Of Contents

    Table of contents A. Introduction ………………..…………………………………………….3 B. Indication for use ……………….………………………………………3 C. Contraindications …………………..……………………………………4 D. Precautions ………..……………………………………………………..4 E. Warnings ………..…………………..……………………………………5 F. Safety Instructions before use …………………………………………….6 G. Important Notes ………………………………………………………….7 1. Battery …………………………………………………………………………7 2. Collection Canister ……………….…………………………………….………….8 3. Dressing ……….…………………………………………………………………. H.
  • Page 3: Introduction

    A. Introduction Thank you for your choosing the Carilex VT・100 device for use in negative pressure wound therapy (NPWT). PLEASE READ THIS INSTRUCTIONS FOR USE CAREFULLY BEFORE USING THIS DEVICE. VT・100 is an advanced suction therapy unit that is part of an integrated wound management program.
  • Page 4: Contraindications

    C. Contraindications Contraindicated for patients with the following conditions: ! Presence of necrotic tissue ! Malignancy ! Untreated Osteomyelitis ! Untreated malnutrition ! Exposed arteries, veins, nerves, or organs ! Use over anastomotic sites D. Precautions Precautions should be taken for patients with the following conditions: "...
  • Page 5: Warnings

    To reduce the risk of transmission of blood-borne pathogens, regardless of their diagnosis or presumed infection status, all patients should take medical standard operating procedure precautions against infection control. In addition, a healthcare provider should wear gloves, a gown, and goggles if there is the possibility of contact with the patient’s body fluids. E.
  • Page 6: Safety Instructions Before Use

    If obvious defects might restrict safe operation In any case, remove the power supply adapter from the electrical socket and have the unit checked by qualified personnel authorized by Carilex® Medical. " The VT ・ 100 therapy unit must be placed carefully and securely at the patient’s beside. An optional carrying bag is available for mobile use;...
  • Page 7: Important Notes

    The safety standard of the VT ・ 100 therapy unit corresponds with recognized medical and technical regulations and the guidelines relating to medical products. " Opening the unit should only be performed by qualified personnel authorized by Carilex® Medical. "...
  • Page 8: Collection Canister

    Upon initial receipt of the VT・100 therapy unit and prior to first use, charge the battery for at least 4 hours in order to create optimum battery memory and to maximize the number of charging cycles over the lifetime of the battery. The battery must be fully charged prior to first use of the VT・100 therapy unit.
  • Page 9: Dressing

    NOTE: DO NOT re-use the canister to avoid the cross infection in between the patients. 3. Dressing Only Genuine Carilex Dressing Kits are to be used in conjunction with the VT・100 system and must be in sterile condition. Carilex Dressing Kits should be applied in accordance with the Dressing Kit Instructions for Use, supplied with the dressings.
  • Page 10: Operating

    H. Operating 1. Illustrations VT・100 Therapy unit and collection canister Canister lid Connector U-2S1001-30161 V1.6 Page 10 of 23...
  • Page 11: Display Panel And Screen

    2. Display Panel and Screen (a) Power (e) Ok/Unlock /Stop (b) Alarm mute/Return (f) Arrow down (c) Light for display screen (g) Display screen (d) Arrow up 3. Symbols and keys Battery status. Battery depletion or low power. It needs to be charged and display shows Battery Low Battery cannot charge, please contact to your distributor for service.
  • Page 12: Operation Procedure

    Warning with alarm. The machine is running. Call for Service. 4. Operation Procedure 4.1 Using the function keys (a) Power Press and hold button for 3 seconds to turn on the power unit . (b) Alarm mute/Return You may press button to turn off the audible alarm after notified.
  • Page 13 " Immediately after switching on the display is illuminated with VT-100. Press OK key if you want to continue with previous settings or wait for 5seconds until on the display the following appears: " keys to move the cursor to the...
  • Page 14 You can choose between -30mmHg to -200mmHg. Default pressure is -125mmHg. When having selected continuous therapy the picture to the right appears on the display " Use the key to set prescribed pressure and -5mmHg per press. Confirm the selected pressure with key and power units starts to work.
  • Page 15 Intermittent Mode Setting Therapy unit changes between two phases with different prescribed pressure and different time interval settings. There is high and low pressure setting available: High pressure setting is from -50mmHg to -200mmHg. Default is -80mmHg. High Pressure time setting range is: 1to10minutes, Default is 5minutes.
  • Page 16: Reminder

    for 3seconds. The display screen turn dark for power saving after 3 minutes. " The display screen only display the current pressure while operating. To see details, press key and the details on display screen appears for 5seconds. " If the treatment must be interrupted, stop the unlocked therapy unit by pressing the key, immediately the therapy unit will stop and the screen as to the right will appear.
  • Page 17: Trouble-Shooting

    Alarm error messages appear on the display: Error Message remedy Display Possible causes Dressing is not ・Press mute key to mute the tight Tube not alarm Leak correctly ・Seal the dressing correctly connected or ・Power unit will go back in leaks in the operation mode after problem is dressing.
  • Page 18: Cleaning And Maintenance

    3. Check if the unit is still in the 3. Complete the settings setting mode 1.Check if the tube is partially 1. Remove kinks and or kinked or the clamps are release clamps. engaged 2.Check system for leaks 2. Connect the tubing / Insufficient performance canister properly.
  • Page 19: Disposal

    Power unit: Wear suitable gloves for cleaning / disinfection. Routine cleaning of power unit can be done by wiping down with damp cloth using disinfectant and water or non-aggressive cleaning material. Warning Take special precaution to ensure that no cleansing solution is able to penetrate into the equipment.
  • Page 20: Technical Date

    L. Technical Data Air flow rate of therapy unit 2.5 liters/min Negative pressure Max.-200mmHg (-27kPa) Power Input: AC 100-240V / 47-63Hz Power Output DC 9V 3A Power Consumption Max: 27W Continuous: Pressure range:-30~-200mmHg Default: -125mmHg Time setting: 1~10minutes Intermittent: Operation mode Pressure range: High -50~200mmHg Default: -80mmHg Low -20~-80mmHg...
  • Page 21 Dimensions (WxHxD) W18 cm(7 in) x H17 cm(6.7 in) x D9.0 cm(3.5 in) Weight (basic unit) 1.35 kg(3 lbs) with canister Canister Capacitor 300cc/ml or 500cc/ml Against ingress of solid foreign objects 12.5 mm diameter. IP21 Against ingress of water with harmful effects – vertically dripping. Risk class in accordance with MDD 93/42/EEC as amended by 2007/47/EC Annex IX...
  • Page 22: Signs And Symbols

    M. Signs & Symbols Consult instructions for use Type BF Degree of shock protection acc. to IEC 60601-1 UL Classification CE mark Date of Manufacture Manufacturer Do not re-use Packaging unit for VT・100 canister U-2S1001-30161 V1.6 Page 22 of 23...
  • Page 23: Warranty

    N. Warranty There is a two year warranty for Carilex VT・100 powered suction therapy unit. Warranty card is included in packaging and should be filled out and returned to the manufacturer. When repairing during the warranty period, charges may still be applicable in the following conditions: a.

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