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Masimo softFlow Operator's Manual
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Masimo softFlow Operator's Manual

Masimo softFlow Operator's Manual

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Operator's Manual
Masimo softFlow™

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Summary of Contents for Masimo softFlow

  • Page 1 Operator's Manual Masimo softFlow™...
  • Page 3 • Keep these instructions for use ready at hand for future reference. • Before first use, the Masimo softFlow™ system must undergo a setup and configuration process. The device must be cleaned regularly and particularly between patients. • For additional information and support, please contact your local Masimo representative. See 7 Service/User Assistance Information on page 65.

  • Page 5: Table Of Contents

    2.2 Applicators ----------------------------------------------------------------------------------------------------------------- 18 2.3 Oxygen Supply ----------------------------------------------------------------------------------------------------------- 31 2.4 Configuration -------------------------------------------------------------------------------------------------------------- 32 3 Operation ------------------------------------------------------------------------------------------------------------------------- 37 3.1 softFlow and junior Mode ---------------------------------------------------------------------------------------------- 37 3.2 Therapy Parameters ---------------------------------------------------------------------------------------------------- 38 3.2.3 Oxygen ------------------------------------------------------------------------------------------------------------------- 40 3.3 Start Therapy ------------------------------------------------------------------------------------------------------------- 41 3.4 Troubleshooting ---------------------------------------------------------------------------------------------------------- 42 4 Reprocessing ------------------------------------------------------------------------------------------------------------------- 47 4.1 Cleaning and Disinfection --------------------------------------------------------------------------------------------- 47...

  • Page 7: Overview

    1 Overview During therapy with the Masimo softFlow™ system, the patient is supplied with an air flow of warmed, almost completely moisture-saturated air. Technically, the Masimo softFlow™ device consists of a ventilation and a humidifier unit. The flow generator draws in ambient air and then compresses it. In the humidifier unit, water is heated until it evaporates, thus moistening the therapy air.
  • Page 8 • The system may only be used by prescription by a physician as per his/her instructions. • The Masimo softFlow system may only be operated by a mentally alert person, possibly a qualified third person. This must be taken into account especially when the appliance is used in children.
  • Page 9 • Do not use the Masimo softFlow system in MRI environments, near HF surgical equipment or in other environments where the intensity of the EM disturbances is high! • Do not use the Masimo softFlow at an altitude above 3000 m AMSL as the therapy quality might be affected due to low ambient pressure.

  • Page 10: System Components

    Power Cord Connector Enter Button Oxygen Cap General Description The Masimo softFlow system includes the following: • Masimo softFlow • Power Cord • Humidifier Rack Clinic (when delivered to healthcare institutions) • Humidifier Clinic Hygiene Set (when delivered to healthcare institutions) •...
  • Page 11 Masimo softFlow 1 Overview softFlow Mode When in softFlow mode, the nasal or tracheal applicators are used: Nasal Item Description Item Description Applicator Plug Patient Nasal Interface Tracheal Item Description Item Description Applicator Plug Tracheal Applicator Connector www.masimo.com Masimo...
  • Page 12 Masimo softFlow 1 Overview junior Mode When in junior mode, the junior applicator is used. The junior applicator is the portion of the system that delivers the gas from the generator and mixing chamber to the patient. The junior applicator is made up of 4 components assembled together.

  • Page 13: Clinical Use

    Masimo softFlow 1 Overview Clinical Use Item Description Heating Plate Humidifier, Clinic Humidification Chamber Auto-Fill Air Bridge Breathing Filter Home Use www.masimo.com Masimo...
  • Page 14 Masimo softFlow 1 Overview Item Description Item Description Humidifier Homecare Cyclone Water Tank, Humidifier Homecare Lid, Humidifier Homecare www.masimo.com Masimo...

  • Page 15: Setup

    • Switch on the device by pressing the rocker switch next to the power socket. Note: The device performs an internal test during startup: An alarm sound must be audible. WARNING: Ensure that the interior of the Masimo softFlow unit is dry before connecting it to the power supply.

  • Page 16: Humidifier

    Humidifier Rack Clinic Breathing Filter Humidification Chamber Auto Fill Air Bridge Masimo softFlow 2.1.2 Assembly of Humidifier Clinic Assemble the humidifier according to the following descriptive picture sequence: 1 Slide the humidification chamber auto fill from below into the dedicated socket of the rack.
  • Page 17 Masimo softFlow 2 Setup 2 Route the Humidification Chamber supply line through the opening in the Humidifier Rack and through the retainers as shown. 3 Push the breathing filter from above into the dedicated socket of the rack. 4 Place the air bridge from above onto the dedicated openings of the rack to connect the filter and the humidification chamber.
  • Page 18 Note: Ensure that the Humidification Chamber and the water bag always contain sufficient amounts of water. Note: Switch off the Masimo softFlow system if not in use. WARNING: Ensure that the water level is always between the black marking lines (see Image)! WARNING: Use sterile water only.
  • Page 19 Masimo softFlow 2 Setup 2.1.4 Components of Humidifier Homecare The homecare humidifier consists of three parts: 1. Humidifier Lid 2. Humidifier Cyclone Element 3. Humidifier Water Chamber 2.1.5 Assembly of Humidifier Homecare Assemble the humidifier according to following descriptive picture sequence: 1 Fill the water chamber with purified, distilled or sterile water up to the "max."...

  • Page 20: Applicators

    Masimo softFlow 2 Setup 3 Close the lid and lock it by lowering the locking tabs. 4 Carefully push the Humidifier Homecare complete into the device. Close the housing front lid by flipping it up. WARNING: Empty the humidification chamber completely before shipping the device! 2.1.6 Water Refill in Humidifier Homecare...
  • Page 21 Warning: To avoid the risk of injuries and damage: • Do not use accessories that are not authorized by Masimo. • Do not use insulating sleeves and do not cover the applicator when in use (e.g. by a blanket).
  • Page 22 Masimo softFlow 2 Setup 2 Insert the ApplicatorModule junior from above into the dedicated socket and push it down gently and fully. 3 Remove the InnoTube and the connection plug from the packaging and insert the connection plug (1) into the InnoTube (2).
  • Page 23 Masimo softFlow 2 Setup 6 Insert the angled connector of the Temperature Measuring Element into the dedicated socket at the front end of the InnoTube 7 Insert the plug of the sensor cable into the dedicated socket on the front side of the ApplicatorModule junior.
  • Page 24 Masimo softFlow 2 Setup 9 The Masimo softFlow is now equipped correctly with the Applicator. Put the system into operation according to the instructions of the manual and attach the applicator correctly. Note: To meet the requirements of the ongoing therapy, be sure to choose the appropriate nasal cannula.
  • Page 25 Masimo softFlow 2 Setup 2.2.4 Uninstalling the Applicator (junior Accessories) 1 Remove the plug of the sensor cable from its socket on the on the front side of the ApplicatorModule. 2 Remove the temperature measurement element from its socket on the free end of the InnoTube.
  • Page 26 Masimo softFlow 2 Setup 4 Remove the end of the InnoTube from its socket on the ApplicatorModule. 5 Move the locking lever under the ApplicatorModule to the right. The ApplicatorModule is released from its lock. 6 Pull the ApplicatorModule straight up from the socket.
  • Page 27 Masimo softFlow 2 Setup 2.2.5 Nasal Application Turn on the Masimo softFlow device to start therapy before attaching an applicator. Attach the applicator to the patient’s face according to the following picture sequence. softFlow Mode 1 Make sure that the slightly curved prongs point towards the face.
  • Page 28 Masimo softFlow 2 Setup junior Mode Make sure that the slightly curved prongs point towards the face. Carefully insert the prongs into the nose. Remove the protective sheet from the self-adhesive pads and fix them on the cheeks of the patient.
  • Page 29 2.2.6 Tracheal Application Turn on the Masimo softFlow device to start therapy before attaching an applicator. Attach the applicator to the patient’s tracheostomy interface according to the following sequence of images.
  • Page 30 Note: This accessory can only be used with the system operated in softFlow mode. Note: When the Tracheal Interface Applicator is connected to softFlow, the dew point setting is automatically set to 37°C to allow >33 mg/l for tracheal applications. The dew point setting cannot be adjusted when the Tracheal Interface Applicator is connected.
  • Page 31 Masimo softFlow 2 Setup 2.2.7 Applicator-Accessories Applicator-Clip Place the applicator clip at the desired position on the applicator tube with the label facing upwards. Place the band around the applicator hose. Pull the band through the provided opening of the clip.
  • Page 32 Masimo softFlow 2 Setup Tighten the band only to the extent that the hose is not squashed in any case. Wind the band completely. Open the fastening clip and attach it to the desired position on your clothing. www.masimo.com Masimo...

  • Page 33: Oxygen Supply

    2.3 Oxygen Supply If supplemental oxygen is required, an external, medically approved oxygen source can be connected to the Masimo softFlow device using the lateral oxygen inlet port. The oxygen inlet port is located on the left side of the device casing.

  • Page 34: Configuration

    Masimo softFlow 2 Setup WARNING: Do not operate the device in closed rooms producing or using anesthetics and/or nitrous oxide. WARNING: Keep the oxygen valves free of oil, grease or any flammable liquids. WARNING: Keep the device at a min. distance of 40 cm from the floor and from the wall and a min.

  • Page 35: Language, Date And Time

    Masimo softFlow 2 Setup User Menu 1 Scroll Up or Increase Value 2 Scroll Down or Reduce Value 3 Confirm Selection/Adjusted Value 4 Exit User Menu 2.4.2 Language, Date and Time Language Enter the user menu and select the tab Language. Scroll to the desired language and confirm the selection.

  • Page 36: Alarm Volume

    Masimo softFlow 2 Setup Setting: Time Enter the user menu and select the tab Time. Select the desired format and confirm the selection. Use the arrow keys to set the correct time. Confirm the setting. It is saved in the system’s memory.

  • Page 37: New Patient

    The Masimo softFlow system continuously records the patient’s therapy hours. Enter the user menu and select Therapy hours to read out the therapy hours. Note: All data on operation and dysfunction are recorded and can be read out by Masimo technical staff or an authorized Masimo representative.

  • Page 39: Operation

    The Masimo softFlow system can be operated in two modes: softFlow mode and junior mode. The softFlow mode enables flow rates from 10 to 60 l/minute while the junior mode is used for flow rates from 2 to 15 l/min.

  • Page 40: Therapy Parameters

    3.2.1 Flow Rate • Turn on the Masimo softFlow device to start therapy. • Select the parameter Flow in the user menu. • Adjust the flow rate in 0.5 l/min steps to the value, that is suitable to the particular applicator type, and confirm the selected nominal value.
  • Page 41 Masimo softFlow 3 Operation User Menu: Setting: Nominal value in the footer: 3.2.2 Humidity • Select the parameter Humidity in the user menu. • Increase the dew point temperature (in 1°C DP steps, within the range from 30-37°C DP) to increase the humidity or vice versa by pressing the arrow keys.

  • Page 42: Oxygen

    Note: For optimal humidification of the patient’s mucosa, humidity of 34-37°C DP during therapy is recommended. Note: When the Tracheal Interface Applicator is connected to softFlow, the dew point setting is automatically set to 37°C to allow >33 mg/l for tracheal applications. The dew point setting cannot be adjusted with the Tracheal Interface Applicator connected.

  • Page 43: Start Therapy

    Mode on page 37. Press Start/Stop key to start therapy. Current Patient If the device was turned OFF - Turn Masimo softFlow by pressing the rocker switch next to the power socket. Wait for device self test to be completed. www.masimo.com...

  • Page 44: Troubleshooting

    Please contact your Masimo representative. See 7 Service/User Assistance Information on page Note: If an error is displayed, which is not listed in the following table, please contact your Masimo representative. See 7 Service/User Assistance Information on page 65.
  • Page 45 Masimo softFlow 3 Operation Error Severity Notification Interpretation code code No flow Flow rate is zero.* Flow rate not Measured flow is lower than the set flow. Please check air flow reachable and applicator type. Verify the applicator for any obstructions or kinks.
  • Page 46 Calibration Error Restart device with closed oxygen supply. Slowly reopen oxygen after the device has reached set air flow completely.* Note: This error code will not appear on newer softFlow devices with the O Quick Start label affixed above the lateral oxygen inlet.
  • Page 47 Press the enter button (checkmark) to acknowledge. * Turn off the main switch of the device. Wait at least 30 sec. before restarting the device. If the error persists, please contact your Masimo representative. See 7 Service/User Assistance Information on page 65.

  • Page 49: Reprocessing

    Note: Switch off the device and disconnect it from the power supply before processing. Note: Check all components for visible damage after cleaning/disinfection. Note: Assemble the Masimo softFlow components according to these instructions for use and check for proper functioning.

  • Page 50: Manual Disinfection

    Note: The disinfection procedure according to the Keredusy procedure can be performed by the manufacturer Masimo or another authorized company / institute. Three Keredusy procedures may be performed at maximum. If you have any questions, please contact Masimo. See 7 Service/User Assistance Information on page 65.

  • Page 51: Cleaning And Replacement Cycles

    IPA* Hydrow USP Isopropyl Alcohol 70% Chlorhexidine* Hibiclens Chlorhexidine 4.0% Applicator Headgear softFlow Isopropyl Alcohol Isopropyl Alcohol 70% Ethyl Alcohol Ethyl Alcohol 70% * Also suitable to disinfect the Humidifier rack Clinic. The agent’s disinfecting efficiency was validated by the respective disinfectant manufacturer. Please follow the instructions for use provided by the cleaning / disinfectant’s manufacturer.
  • Page 52 Masimo softFlow 4 Reprocessing Component Cleaning Cleaning Method Replacement Cycle Usage Cycle junior Cannula Follow cannula Single patient manufacturer's multiple use guidance. InnoTube softFlow 30 days Single patient multiple use Clinic System Humidifier rack clinic Between Manual cleaning Reusable Patients...
  • Page 53 Masimo softFlow 4 Reprocessing 4.3.1 Dust Filter Change • Weekly, rinse the dust filter under running water, wring it out and let it dry completely before putting it back in the holder. • At least every 3 months or with error “851-Change dust filter” is displayed (whichever is earliest).

  • Page 55: Product Specifications

    5 Product Specifications Performance Data softFlow Mode Performance Data Flow Rate 10 to 60 l/min (adjustable in 0.5 l/min steps) Admixture of oxygen 0 to 60 l/min junior Mode Performance Data Flow Rate 2 to 15 l/min (adjustable in 0.5 l/min steps)
  • Page 56 Masimo softFlow 5 Product Specifications Technical Data Safety class, electrically Alarm signal sound pressure > 45 dB (A) Safety type IP21: Protected from touch by fingers and objects >12 mm and dripping water Applied part (applicator) Electrical safety According to EN 60601-1 UL 60601-1 CSA C22.2/No 60601-1...
  • Page 57 -29°C to +70°C Humidity < 93% RH Ambient air pressure 700 hPa to 1060 hPa Electromagnetic compatibility EN 60601-1-2: 2007 Filter class of dust filter G4 (EN 779: 2003) Expected operating time (expected service life) Masimo softFlow 6 years www.masimo.com Masimo...

  • Page 58: System Information

    Note: The Service menu can be accessed by a Masimo technical staff or representative only. Homecare Mode The configuration of a Masimo softFlow device needs to be changed from clinic to homecare mode if a patient continues therapy at home. Please contact your Masimo representative. See 7 Service/User Assistance Information on page 65.

  • Page 59: Storage And Transport Conditions

    All data on operation and dysfunction of the Masimo softFlow system are recorded during therapy hours and can be read out by Masimo technical staff. These data are stored in the internal memory. The internal memory has the capacity to store all data collected during the previous 12 months. Additionally, an SD card can be used to save data independently of the internal memory.
  • Page 60 Complies emissions IEC 61000-3-3 Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Masimo softFlow system is intended for use in the electromagnetic environment specified below. The user must ensure that these requirements are met. Immunity Test IEC 60601 Test Compliance...
  • Page 61 If the measured field strength exceeds the applicable RF compliance level of the Masimo softFlow system, its correct operation has to be regularly verified. If malfunction is observed, additional measures may be necessary such as relocating the Masimo softFlow system.
  • Page 62 Recommended Separation Distance Between Portable and Mobile RF Communication Equipment and the Masimo softFlow system The Masimo softFlow system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a...

  • Page 63: Symbols

    Masimo softFlow 5 Product Specifications 5.5 Symbols Symbol Description Symbol Description Follow the instructions for use Consult instructions for use Separate collection for European Union Conformity Mark electrical and electronic equipment (WEEE) Protection from ingress of particulates > 12.5 mm and against...

  • Page 64: Disposal

    You may dispose of the following parts with the domestic waste: applicators, humidifier rack clinic, air bridge humidifier clinic, breathing filter, dust filter, humidification chamber auto-fill. The Masimo softFlow unit contains electronic components. Do not discard with regular waste. Please contact your local Masimo representative regarding the unit’s disposal.

  • Page 65: Warranty

    6 Warranty LIMITED WARRANTY: THE MASIMO SOFTFLOW DEVICE WAS MANUFACTURED WITH CARE AND TESTED IN DETAIL BEFORE SHIPMENT. THE WARRANTY PERIOD IS 2 YEARS FROM THE DATE OF PURCHASE (ACKNOWLEDGED BY AN INVOICE AND/OR GUARANTEE CERTIFICATE WITH DEALER STAMP). TNI MEDICAL AG WILL REPLACE DEFECTIVE PARTS OF THE DEVICE WITHIN THE WARRANTY PERIOD.

  • Page 67: Service/User Assistance Information

    TNI Medical AG only. Note: Maintenance of the Masimo softFlow system lies within the responsibility of the user / clinic. Note: Repair / service may only be carried out by a service technician authorized by Masimo.
  • Page 70 302679/LAB-11277G-0523...