Invia® Ease Negative Pressure Wound Therapy system EN Clinician Instructions for Use
For Clinician Use Only Please read all instructions before using this product. Keep these instructions for future reference. – 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.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 Introduction ��������������������������������������������������������������������������������������������������������������������������� 4 Intended use �������������������������������������������������������������������������������������������������������������������������� 4 Indications for use ����������������������������������������������������������������������������������������������������������������� 5 Contraindications ��������
1 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. Invia Ease NPWT system is intended to be used in conjunction with the Invia dressings only. 2 Intended use 2.
EN 3 Indications for use The Invia Ease Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as when used on open wounds it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudates and infectious material.
5 Safety information WARNING Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation that, if not avoided, could result in minor or moderate injury. NOTICE Can lead to material damage (not related to personal injury). i INFORMATION Useful or important information that is not related to safety.
Safety information | 7 EN – Small adults and elderly patients as well as patients with highly exudating wounds should be closely monitored for fluid loss and dehydration. When needed, fluid output in the canister and tubing should be compensated accordingly to avoid excess fluid loss and dehydration.
– Prior to charging, 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. – Never operate the pump if it is not working properly, if it has been damaged or dropped into water. – Do not take the pump into a bathtub or shower. – Never place or drop the pump into water or other liquids. – If the pump has been exposed to water or other liquids, do not touch it.
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. Monitor patient comfort, signs of wound infection, integrity of the dressing, volume of fluid in the canister and therapy compliance. 4.
5.3 Safety measures 1. Only use products specified in these Instructions for Use. 2. Do not modify the Invia Ease pump or any of the system components without authorization 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. Medela can only guarantee the effective performance of the system with these products. 4.
For ordering information refer to chapter 26.
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. The light indicator conveniently shows the therapy status and is easily visible from a distance.
EN 6.
6.4 Invia Ease canister and tubing NOTICE Select the appropriate canister size depending on the wound type. Canister sizes: Tubing length: Tubing inner diameter: 300 ml, 500 ml and 1000 ml 1.5 m 2.0 mm/3.
EN 6.5 Invia Ease charger WARNING • Only use the charger that comes with the pump. An inadequate power source may result in a fire hazard, electric shock or malfunction of the pump. • 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.
6.6 Accessories Invia Y-Connector with Quick-Connector NOTICE For warnings and cautions of the Invia Y-Connector with Quick-Connector consult the Invia Y-Connector with Quick-Connector Instructions for Use. Invia Y-Connector with Quick-Connector is intended to connect two dressing tubings to a single Invia Ease pump. Invia Ease carrying case NOTICE The carrying case is for a single patient use only. The carrying case is designed to more conveniently carry around a pump, which does not include a handle.
EN 6.7 Spare parts For ordering information refer to chapter 26.
7 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. i INFORMATION For instructions, refer to chapter “Battery status and charging” on page 20.
EN Select the preferred language from the list. Click to continue. Program the date and time: – Choose between / or format – To set date (day, month, year) and time (hours, minutes) press or Click to continue. Select the method to access the Clinician menu. This prevents patients from changing any settings. Choose between a Disclaimer or a Code. Click to continue. Disclaimer Code Access the clinician menu with a Access the Clinician Menu by entering a code: swipe.
8 Operating instructions WARNING Never operate the pump if it is not working properly, if it has been damaged or dropped into water. If damage is found, contact the Medela Customer Service or the system provider. The Invia Ease NPWT system is intended to be used by clinicians or by adequately trained lay users (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.
EN 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. Connect the charger to the charging port. The LED light on the charger will illuminate white when the charger is correctly connected to the pump’s charging port. 2.
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 – The touch screen will display that the pump is charging. – If there is no user interaction after 1 minute, the touch screen will enter sleep mode. – The pump is fully charged after approximately 4 hours.
EN 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. • Canisters are designed for single patient use only and cannot be reused. 1. Select the appropriate canister size depending on the wound type (300 ml, 500 ml, 1000 ml). 2. Unpack a new sterile canister. 3.
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. T he light indicator will illuminate yellow and the start-up screen will appear.
EN 8.6 Start new therapy 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. i For instructions, refer to chapter “Turn pump ON” on page 24. 2. To start new therapy: In default settings Click Change settings first Click instructions on how to change therapy settings i For refer to chapter “Change therapy settings” on page 34.
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. The pump may be paused for a variety of reasons including: – To change the wound dressing.
EN 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. • Change the canister a minimum of once a week or when: – The canister appears full – “Canister full” alarm appears on the touch screen 1. Click and hold for 3 seconds on the Main screen.
4. P ress 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. i 6. Connect canister tubing to the dressing tubing. For instructions, refer to chapter “Connect canister tubing to dressing tubing” on page 24. i 7. Open the clamp on the dressing tubing and make sure the canister tubing is unclamped. 8.
EN 8.11 Detach the pump from the patient NOTICE To detach the pump from the patient, therapy must be paused. 1. Click and hold i for 3 seconds on the Main screen. For instructions to detach from the pump click on the Pause screen i To exit the instructions at any time, click 2. P osition the clamps next to the Quick-Connector and close clamps on the canister tubing and the dressing tubing. 3. D isconnect the canister tubing from the dressing tubing by pressing the sides of the Quick-Connector.
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. For detailed information regarding dressing applications, consult the appropriate Invia i dressing Instructions for Use. 1.
EN 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. i For instructions on how to end therapy refer to chapter “End therapy” on page 40. To turn the pump off either: OR 1.
8.14 Resume existing therapy (after the pump was turned off) 1. Press the “On/Off” button 2. C lick to turn the pump on. to resume existing therapy. i To start new therapy click i For instructions, refer to chapter “Start new therapy” on page 25. NOTICE New therapy should only be started by a clinician.
EN 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: – Change therapy settings – Change pump settings – Check the history and log file of the existing therapy – End therapy To access the Clinician menu: 1. Select screen.
10 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. i For instructions, refer to chapter “Access the Clinician menu” on page 33. 2. C lick 3. S elect between therapy modes. or 4.
EN 11 C hange 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. i For instructions, refer to chapter “Access the Clinician menu” on page 33. 2. C lick 3. C lick 4. S elect the field that needs to be changed per instructions on the following pages. 5. Click to return to the Clinician menu.
11.1 Date and time 1. Choose between 2. C lick or / or format. 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. Code Access the Clinician menu with a default code 1111 or set an additional code.
EN 11.3 Alarm volume Select the sound of the acoustic alarm. The sound always starts low and continues to get louder until it reaches its maximum volume. The default alarm volume setting is Medium. 11.3 Vacuum intensity Select the speed at which the negative pressure is applied and the dressing compresses. The Low vacuum intensity requires the longest time to apply the target negative pressure while the High vacuum intensity is the quickest to apply the target negative pressure at the dressing.
12 V iew therapy history 1. Access the Clinician menu. i For instructions, refer to chapter “Access the Clinician menu” on page 33. 2. C lick 3.
EN 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. wish to temporarily interrupt therapy, please refer to chapter “Turn pump off i Iftoyou temporarily interrupt therapy” on page 31. To end existing therapy either: 1. Access the Clinician menu. OR instructions, refer to chapter i For “Access the Clinician menu” on page 33. 1. Press the “On/Off” button 2.
14 Alarms and troubleshooting 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.
EN 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.
“Medium priority” alarms: – Therapy may automatically pause – Status indicator illuminates yellow and flashes Alarm type Potential cause Troubleshooting instructions Notes Pause reminder The therapy has been paused for 30 minutes or longer • To resume the therapy click After 90 minutes in the pause therapy mode, the “Pause reminder” alarm will display an additional warning regarding dressing change • To remain in the pause therapy mode, click Battery empty Battery charge is 5 % or below Charge th
Potential cause Troubleshooting instructions Notes High Leakage The pump detects an air leak in the system and cannot maintain the target level of negative pressure • Inspect the dressing for an air leak • Press firmly around the edges of the dressing and around the Invia FitPad • Apply additional film around the dressing if needed to seal the leak • Check that the Quick-Connector is securely attached • Check that canister is fully connected to the pump • Release and reposition the canister if needed •
15 A ccessories 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. S lide the pump with canister attached into the designated slot. 3. C lose the Velcro over the pump and over the canister. Make sure that the canister tubing is not kinked and the status indicator is visible. 4. S ecure additional tubing with a Velcro on the side of the pump.
EN To exchange a canister from the carrying case: 1. Detach the handle strap on the side of the canister. 2. O pen the Velcro over the canister. 3. U nzip the carrying case from the canister side. 4. C hange the canister. For instructions, refer to chapter “Change a canister” i on page 27. 5. Zip up the carrying case from the canister side.
6. Close the Velcro over the canister. 7. Re-attach the handle strap on the side of the canister.
EN 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. A lign the two handle parts and fixate the screws inside the two holes. 3. C over the screws with the two hole covers from the pump.
15.3 Invia Ease IV pole/bed holder To attach the IV pole/bed holder to an IV pole or a bed board (up to 50 mm): 1. Turn the knob left to open the IV pole/bed holder. 2. P osition the open holder in the center of the IV pole or over the bed board. 3. T urn the knob to the right to firmly secure the holder onto the IV pole or the bed board. To mount the Invia Ease pump onto the IV pole/bed holder: 1. Hold the pump by the handle and position the base of the handle over the IV pole/bed holder. 2.
EN 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. – If any damage or safety defects are observed, contact the Medela Customer Service or the system provider. – Devices of protection class II do not have a protective earth conductor therefore there is no need to check the earth leakage current.
19 Cleaning, disinfection and storage Reusable devices and components from Medela are delivered non-sterile and are intended for reuse. Prior to use, clean and reprocess the product by following the procedure in the Cleaning and Disinfection instructions below.
EN To disinfect the Invia Ease pump and the accessories (charger, handle and IV pole fixation): 1. Wear suitable protection (clothing, gloves, face mask and goggles) according to the facility guidelines. 2. A pply the disinfectant agent in accordance with instructions from the manufacturer. Pay particular attention to the edges, narrow corners, and bottom side. 3. L eave the disinfection agent on for the time recommended by the manufacturer. 4.
21 International regulations 21.1 Electromagnetic compatibility (EMC) The Invia Ease pump is intended to be used in the professional healthcare facility environment and home healthcare environment and is EMC tested in conformity with the requirements of the standard IEC 60601-1-2:2014 4th Edition according to clause 7 and 8.9. The pump needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in these instructions for use.
EN 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. Emission tests Compliance Electromagnetic environment – g uidance RF Emissions CISPR 11 Group 1 The Invia Ease pump uses RF energy only for its internal function.
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 0 % U T for 0.5 cycle at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315° 0 % U T for 0.
EN 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.
F ield strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
vacuum range –40 to –200 mmHg –5 to –27 kPa low flow 5 l/min. without canister 1.1 kg 2.4 lbs EN 22 Technical specifications HxWxD 125 x 175 x 90 mm 4.92 x 6.89 x 3.54 inch max. noise level alarm noise level 35 dBA 62/68/74 dBA (250 ml/min; 125 mmHg) Switching adapter AC Model: MSA-C2500IS12.0-30C-ZZ IEC: 60601-1 Input: 100–240 VAC, max 0.8 A, 50/60 Hz Output: 12 VDC, 2.
23 Material Item description Raw material description Raw material information Invia Ease pump (base unit) Pump housing (upper and lower part) is made of ABS material. The silicone seal in between is made of silicone material. Housing: ABS Housing seal: MQ Elastosil Invia Ease charger Charger housing is made of PC material, plug is made of ABS.
EN 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. 1 Symbols on the motor unit MD Indicates the part number of the device. 7 This symbol indicates the item is a medical device. X Indicates the serial number Defines a temperature of the device. 8 range (e.g. for operation, transport or storage).
Symbols on the power adapter Indicates the compliance with additional USA and Canada safety requirements for medical electrical equipment. 11 The CE mark indicates conformity with the European low voltage and electromagnetic compatibility directive.* Indicates alternating current. 17 Do not dispose of electric/ electronic devices together with unsorted municipal waste (dispose of the device in accordance with local regulations). 10* Identifies the manufacturer.
EN Symbols on the handle and IV pole/bed holder Indicates the part number of the device. 7 Indicates the date of manufacturing. 6 Identifies the manufacturer. 5 Contains fragile goods. Handle with care. 14 Keep away from rain. Keep This symbol indicates a in dry conditions. 16 carton package. X Indicates that the package is capable of being recycled. 17 References 1 IEC 60601-1, Medical electrical equipment – Part 1: General Requirements for basic safety and essential performance, Table D.
27 Ordering information Product REF number 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 101037360 Invia Ease handle 101037364 Invia Ease IV pole/bed fixation 101041744 Invia Ease charger US 101041939 Filter gasket with orange O-ring Pump feet Handle attachment covers 62 | Ordering informatio
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Medela AG Lättichstrasse 4b 6340 Baar, Switzerland www.medela.com USA Medela LLC 1101 Corporate Drive McHenry, IL 60050 USA Phone +1 877 735 1626 Fax +1 815 307 8942 info-healthcare@medela.com www.medelahealthcare.
