Medela Invia Ease Clinician Instructions For Use
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Medela Invia Ease Clinician Instructions For Use

Medela Invia Ease Clinician Instructions For Use

Negative pressure wound therapy system
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Invia
Ease
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Negative Pressure Wound Therapy system
EN
Clinician Instructions for Use

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Summary of Contents for Medela Invia Ease

  • Page 1 Invia Ease ® Negative Pressure Wound Therapy system Clinician Instructions for Use...
  • Page 2 – Misuse or failure to follow the instructions in this manual may result in serious or fatal injury to the patient. – Clinician Instructions for Use are intended for healthcare professionals only. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. Medela Customer Service phone: 1-800-435-8316...

  • Page 3: Table Of Contents

    ....................... . 6 Invia Ease NPWT system and accessories .

  • Page 4: Introduction

    The Invia Ease NPWT system is designed to provide Negative Pressure Wound Therapy (NPWT), to help promote wound healing. The Invia Ease system includes the Invia Ease pump, an Invia Ease canister and tubing in a range of sizes (300 ml, 500 ml and 1000 ml) and an Invia Ease charger.

  • Page 5: Indications For Use

    When used on closed surgical incisions, the Invia Ease NPWT system is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of Negative Pressure Wound Therapy.

  • Page 6: Safety Information

    5.1. WARNING 1. Therapy interruption: The recommended application of the therapy with Invia Ease NPWT system is 24 hours without interruption. If therapy is interrupted for more than 2 consecutive hours (120 minutes), the dressing should be changed and therapy restarted by a clinician in order to avoid the risk of infection or sepsis.
  • Page 7 Quick-Connector. 11. Risk of fire, electric shock, or serious burns: – Due to the fire hazard the Invia Ease pump is not for use in potentially explosive environments including oxygen enriched environments and in areas of flammable anesthetics.
  • Page 8 – This pump contains lithium-ion batteries, which bears risk of fire, explosion and burns. – Do not disassemble, crash, or heat the Invia Ease pump above 212 °F (100 °C ), do not incinerate or dispose of in fire. 12. System modification: Do not modify the Invia Ease pump or any of the system components without authorization from the manufacturer.
  • Page 9 CAUTION 1. Incorrect use of the Invia Ease NPWT system may cause pain or injury to the patient. 2. Routinely check that therapy is running and that the negative pressure level and therapy mode are at the prescribed setting. 3. The patient should be monitored regularly according to the physician instructions and facility guidelines.
  • Page 10 2. Do not modify the Invia Ease pump or any of the system components without authoriza- tion from the manufacturer. 3. The Invia Ease pump is verified within the scope of conformity evaluation and is only to be used with products included in the Invia Ease NPWT system and distributed by Medela.

  • Page 11: Invia Ease Npwt System And Accessories

    6 Invia Ease NPWT system and accessories For ordering information refer to chapter 26. Handle Canister and tubing 300 ml, 500 ml and 1000 ml with Quick-Connector IV pole/bed holder Pump Charger Y-Connector with Quick-Connector Carrying case | 11 Invia Ease NPWT system and accessories...
  • Page 12 6.1 Invia Ease pump The Invia Ease pump is a reusable suction pump that provides adjustable negative pressure, constant and intermittent therapy modes, and an electronic measuring and monitoring system. The Invia Ease pump is compact, portable and includes a long-lasting rechargeable battery.
  • Page 13 Motor stops running / Therapy is paused Pause screen Pause therapy timer Open instructions Log dressing change Clinician menu Exit Clinician menu View therapy history Change therapy and pump settings End current therapy | 13 Invia Ease NPWT system and accessories...
  • Page 14 6.4 Invia Ease canister and tubing NOTICE Select the appropriate canister size depending on the wound type. Canister sizes: 300 ml, 500 ml and 1000 ml Tubing length: 1.5 m Tubing inner diameter: 2.0 mm/3.0 mm Canister release button Control lumen...
  • Page 15 • Prior to connecting the charger, always inspect the charger and the cord for damage. If damage is found, immediately disconnect the charger and call the Medela Customer Service or the system provider.
  • Page 16 Invia Ease handle The Invia Ease pump is designed with an option to attach a handle to the pump to more conveniently carry around the pump. The handle should be affixed to the pump via two screws, which are supplied with the handle.
  • Page 17 6.7 Spare parts For ordering information refer to chapter 26. Filter gasket with orange O-ring Handle attachment covers Pump feet | 17 Invia Ease NPWT system and accessories...

  • Page 18: Initial Pump Setup: First Time The Pump Is Turned On

    WARNING Never operate the pump if it is not working properly, if it has been damaged or dropped into water. If damage is found, immediately disconnect the charger and call the Medela Customer Service or the system provider. NOTICE Medela recommends to fully charge the pump battery before its first use.
  • Page 19 – The default code is programmed as 1111. – To set an additional code refer to chapter “Pump settings/Clinician menu access” on page 36. The Invia Ease pump setup is now complete. To proceed either: Turn pump off Turn the pump off by clicking...

  • Page 20: Operating Instructions

    (patients or caregivers). 8.1 Pump positioning – The Invia Ease pump should remain in an upright position or can be placed on its front or its back during use. – If the Invia Ease pump is placed in an inappropriate position (upside-down or on its side), it will lead to the “Pump in the wrong position”...
  • Page 21 The battery level (as a percentage of fully charged) and the battery symbol are displayed at the top of the touch screen: Battery status/battery level and symbol Additional battery symbols/status Battery is charging Battery fault Charging is not possible at this time To charge the pump battery: 1.
  • Page 22 When the pump begins to charge: Therapy is running – The touch screen lights up and the battery symbol indicates that the pump is charging. – If there is no user interaction after 1 minute, the touch screen will enter sleep mode. Pump is turned off –...
  • Page 23 8.3 Attach canister to the pump WARNING Sterile products: Do not use the sterile products if the sterile packaging is damaged, was opened prior to use or has expired. NOTICE • Wear gloves for all operations and apply universal precautions. •...
  • Page 24 8.4 Connect canister tubing to dressing tubing 1. Align both parts of the Quick-Connector and push the Quick-Connector together until you hear a click. click 8.5 Turn pump ON 1. Turn on the pump by pressing the “On/Off” button 2. The light indicator will illuminate yellow and the start-up screen will appear.
  • Page 25 NOTICE • New therapy should only be started by a clinician. • The default therapy setting of the Invia Ease pump is –125 mmHg in constant mode. 1. Turn the pump ON. For instructions, refer to chapter “Turn pump ON” on page 24.
  • Page 26 8.9 Pause therapy WARNING Therapy interruption: The recommended application of the therapy with Invia Ease NPWT system is 24 hours without interruption. If therapy is interrupted for more than 2 consecutive hours (120 minutes), the dressing should be changed and therapy restarted by a clinician in order to avoid the risk of infection or sepsis.
  • Page 27 8.10 Change a canister WARNING Sterile products: Do not use the sterile products if the sterile packaging is damaged, was opened prior to use or has expired. NOTICE • To change a canister, therapy must be paused. • Canisters are designed for single patient use only and cannot be reused. •...
  • Page 28 4. Press the canister release button on top of the canister to release and remove the used canister. 5. Unpack a new sterile canister and attach it to the pump. For instructions, refer to chapter “Attach canister to the pump” on page 23. 6.
  • Page 29 8.11 Detach the pump from the patient NOTICE To detach the pump from the patient, therapy must be paused. 1. Click and hold for 3 seconds on the Main screen. For instructions to detach from the pump click on the Pause screen To exit the instructions at any time, click 2.
  • Page 30 6. Open the clamps on the dressing tubing and the canister tubing. 7. To resume the therapy click on the Pause screen. The pump motor will start to work, the Main screen will appear and the light indicator should switch from yellow to green when the target level of negative pressure is reached. 8.12 Change a dressing NOTICE To change a dressing, therapy must be paused.
  • Page 31 8.13 Turn the pump off to temporarily interrupt therapy WARNING Therapy interruption: The recommended application of the therapy with Invia Ease NPWT system is 24 hours without interruption. If therapy is interrupted for more than 2 consecutive hours (120 minutes), the dressing should be changed and therapy restarted by a clinician in order to avoid the risk of infection or sepsis.
  • Page 32 8.14 Resume existing therapy (after the pump was turned off) 1. Press the “On/Off” button to turn the pump on. 2. Click to resume existing therapy. To start new therapy click For instructions, refer to chapter “Start new therapy” on page 25. NOTICE New therapy should only be started by a clinician.

  • Page 33: Access The Clinician Menu

    9 Access the Clinician menu NOTICE • The Clinician menu should be used by clinicians only. • The pump automatically switches to the Main screen 1 minute after the last interaction in the Clinician menu. The Clinician menu can be accessed during running therapy or while therapy is paused. From the Clinician menu it is possible to: –...

  • Page 34: Change Therapy Settings

    NOTICE • Changes to therapy settings should only be made as prescribed by a physician. • The default therapy setting of the Invia Ease pump is –125 mmHg in constant mode. 1. Access the Clinician menu. For instructions, refer to chapter “Access the Clinician menu” on page 33.

  • Page 35: Change Pump Settings

    11 Change pump settings The following settings can be changed from the pump settings menu: – Date and time – Clinician access – Alarm volume – Vacuum intensity – Language – Bluetooth on/off – Reset factory settings 1. Access the Clinician menu. For instructions, refer to chapter “Access the Clinician menu”...
  • Page 36 11.1 Date and time 1. Choose between format. 2. Click to set date (day, month, year) and time (hours, minutes). 3. Click to return to the pump settings menu. 11.2 Clinician menu access 1. Choose between a disclaimer or a code. Disclaimer Access the clinician menu with a swipe.
  • Page 37 – Bluetooth interface is used by the Medela service centers only. 11.7 Factory settings reset The Invia Ease pump can be reset to the default factory settings: – Therapy setting is constant mode in –125 mmHg – Language is English –...

  • Page 38: View Therapy History

    12 View therapy history 1. Access the Clinician menu. For instructions, refer to chapter “Access the Clinician menu” on page 33. 2. Click 3. To check the detailed therapy events , click History screen Exit history screen Therapy start date Therapy ID number Number of dressing changes performed during therapy...

  • Page 39: End Therapy

    13 End therapy NOTICE • The therapy history of the current therapy will be erased once therapy is ended and the pump is turned off. • Therapy should only be ended by a clinician. If you wish to temporarily interrupt therapy, please refer to chapter “Turn pump off to temporarily interrupt therapy”...

  • Page 40: Alarms And Troubleshooting

    2. Follow the instruction shown on the touch screen or refer to the chapter “Alarm table” on page 42. 3. If the problem cannot be resolved, turn the pump off and contact the Medela Customer Service or the system provider for further instructions. For instructions, to turn the pump off refer to chapter “Turn pump Off to temporarily interrupt therapy”...
  • Page 41 Alarm table “Low priority” alarms: – Therapy continues to run – Status indicator illuminates yellow NOTICE ”Low Priority” alarms that are not resolved will lead to “Medium Priority” alarms. To close the instructions after acknowledging the alarm and to return to the Main screen click Alarm type Potential cause...
  • Page 42 “Medium priority” alarms: – Therapy may automatically pause – Status indicator illuminates yellow and flashes Alarm type Potential cause Troubleshooting Notes instructions The therapy has been • To resume After 90 minutes in the Pause reminder paused for 30 minutes the therapy click pause therapy mode, or longer...
  • Page 43 If the problem cannot Pump error internal error be resolved, turn the pump off and contact to turn the pump off the Medela Customer • Press the “On/Off” Service or the system button on the provider for further side of the pump to instructions.

  • Page 44: Accessories Setup

    15 Accessories setup 15.1 Invia Ease carrying case To place the pump inside the carrying case: 1. Open the Velcro on the top of the carrying case. 2. Slide the pump with canister attached into the designated slot. 3. Close the Velcro over the pump and over the canister.
  • Page 45 To exchange a canister from the carrying case: 1. Detach the handle strap on the side of the canister. 2. Open the Velcro over the canister. 3. Unzip the carrying case from the canister side. 4. Change the canister. For instructions, refer to chapter “Change a canister” on page 27.
  • Page 46 6. Close the Velcro over the canister. 7. Re-attach the handle strap on the side of the canister. 46 | Accessories setup...
  • Page 47 15.2 Invia Ease handle To affix the carrying handle to the pump: 1. Remove the two hole covers from the back of the pump. 2. Align the two handle parts and fixate the screws inside the two holes. 3. Cover the screws with the two hole covers from the pump.
  • Page 48 To remove the Invia Ease pump from the IV pole or the bed board: 1. Hold the pump by the handle and lift the pump up to release it from the IV pole/bed holder.

  • Page 49: Safety-Related Checks

    16 Safety-related checks – The Invia Ease pump is a device in protection class II (EN IEC 60601-1), the safety-related checks are confined to visual inspection of the housing and charger for damage. This check must be performed prior to each use.

  • Page 50: Cleaning, Disinfection And Storage

    – Common household cleaner NOTICE • Never use steel brushes or steel wool for cleaning. • Invia Ease pump and accessories (charger, handle and IV pole fixation) should be cleaned and disinfected after every use. WARNING • Never place or drop the pump into water or other liquids.

  • Page 51: Disposal

    • Invia Ease products should be handled and disposed of in accordance with the local environmental guidelines. • The Invia Ease pump or the accessories must not be disposed of with the household refuse. – The Invia Ease pump is made from various metal and plastic parts, which should be disposed of in accordance with the local environmental guidelines.

  • Page 52: International Regulations

    • Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, walkie-talkies, RFID can affect the Invia Ease pump and should be kept at a distance of at least 30 cm away from the device.
  • Page 53 Guidance and manufacturer’s declaration – electromagnetic emissions This Invia Ease pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Invia Ease pump should assure that it is used in such an environment.
  • Page 54 1 cycle 0 % U for 1 cycle hospital environment. If at 0° at 0° Voltage dips, short the user of the Invia Ease interruptions and pump requires continued 70 % U 70 % U voltage variations operation during power...
  • Page 55 Guidance and manufacturer’s declaration – electromagnetic immunity This Invia Ease pump is intended for use in the electromagnetic environment specified below. The customer or the user of the Invia Ease pump should assure that it is used in such an environment.
  • Page 56 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Invia Ease pump is used exceeds the applicable RF compliance level above, the Invia Ease pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Invia Ease pump.

  • Page 57: Technical Specifications

    22 Technical specifications vacuum range low flow without canister H x W x D –40 to –200 mmHg 5 l/min. 1.1 kg 125 x 175 x 90 mm –5 to –27 kPa 2.4 lbs 4.92 x 6.89 x 3.54 inch max.

  • Page 58: Material

    23 Material Item description Raw material description Raw material information Invia Ease pump (base unit) Pump housing (upper and lower Housing: ABS part) is made of ABS material. Housing seal: MQ Elastosil The silicone seal in between is made of silicone material.

  • Page 59: Meaning Of Symbols

    26 Meaning of symbols The following tables explain the meaning of the symbols found on the product parts and its packaging. Symbols used in these instructions General safety alert symbol, points to information related to safety. Symbols on the motor unit Indicates the part number This symbol indicates the Indicates the serial number...
  • Page 60 Symbols on the power adapter Indicates the compliance The CE mark indicates Indicates alternating Do not dispose of electric/ with additional USA and conformity with the current. electronic devices together Canada safety European low voltage and with unsorted municipal requirements for medical electromagnetic waste (dispose of the electrical equipment.
  • Page 61 Symbols on the handle and IV pole/bed holder Indicates the part number Indicates the date of Identifies the manufactur- Indicates that the package of the device. manufacturing. is capable of being recycled. Contains fragile goods. Keep away from rain. Keep This symbol indicates a Handle with care.

  • Page 62: Ordering Information

    Invia Ease NPWT system (pump and charger) 101037357 Invia Ease canister and tubing 300 ml (5pcs) 101037361 Invia Ease canister and tubing 500 ml (5 pcs) 101037362 Invia Ease canister and tubing 1000 ml (3 pcs) 101037363 Invia Ease carrying case...
  • Page 64 Medela AG Lättichstrasse 4b 6340 Baar, Switzerland www.medela.com Medela LLC 1101 Corporate Drive McHenry, IL 60050 Phone +1 877 735 1626 +1 815 307 8942 info-healthcare@medela.com www.medelahealthcare.us Medela Customer Service phone: 1-800-435-8316...

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