Cardinal Health NTrainer System 2.0 Instructions For Use Manual

Hide thumbs

Table Of Contents

Quick Links

Download this manual

NTrainer™ System 2.0

Instructions for Use

IN-P000 REV 5

IN-5000

IN-5001

IN-5002

IN-5005

IN-5006

Table of Contents

Need help?

Do you have a question about the NTrainer System 2.0 and is the answer not in the manual?

Questions and answers

Summary of Contents for Cardinal Health NTrainer System 2.0

Page 1 IN-P000 REV 5 NTrainer™ System 2.0 IN-5000 IN-5001 IN-5002 IN-5005 Instructions for Use IN-5006...
Page 2: Table Of Contents
IN-P000 REV 5 Table of Contents 1. Section 1: Overview ....................5 1.1. About This Manual ..............................5 1.2. Introduction ................................5 1.2.1. Indications for Use ............................5 1.2.2. Intended Patient Population ........................... 5 1.2.3. Product Description ............................5 1.2.4. Unpacking................................
Page 3 IN-P000 REV 5 2.5.3. Edit Patient File ............................. 24 2.5.4. Switch Patient Files ............................25 2.5.5. Mark Patient as Inactive..........................25 2.6. Set Up the Handpiece for Use ..........................26 2.7. Supporting the Infant Before, During and After an Assessment or Therapy Session ........... 27 2.8.
Page 4 IN-P000 REV 5 4.2.1. Cart Assembly Instructions ........................... 48 4.2.2. Assembling UPS Mount ..........................55 4.2.3. Mounting UPS ............................... 57 4.2.4. Assembling Monitor Enclosure ........................59 4.3. Assembled Unit ..............................63...
Page 5: Section 1: Overview
IN-P000 REV 5 1. Section 1: Overview 1.1. About This Manual This manual describes the features and functions of the NTrainer™ System 2.0. Section Overview: Section 1: Overview: Provides an overview of NTrainer™ System 2.0. Section 2: Operation: Guides the user through the first time set-up, turning on the system, completing Assessments and Therapies, reviewing the data and managing users.
Page 6 IN-P000 REV 5 stimulate and entrain brain development. NTrainer™ System 2.0 can be used on its own, during a nutritive gavage feeding or before/after breast or bottle feeds. The use of the NTrainer™ System 2.0 is underwritten by clinical evidence. The NTrainer™ System 2.0 has no essential performance.
Page 7: Unpacking
505NT NTrainer™ System 2.0 Patient Receiver Tubes, 5-pack 510NT NTrainer™ System 2.0 Patient Receiver Tubes, 10-pack IN-5003 NTrainer™ System 2.0 Patient Consumables, 10-pack IN-5004 NTrainer™ System 2.0 Patient Consumables, 20-pack Contact Cardinal Health Customer Service with any questions: Website: cardinalhealth.com Phone:...
Page 8 IN-P000 REV 5 Contents: Quantities in boxes may vary depending on the purchase order. All quantities shown here are to represent assembly only. Part Quantity Image Pole Cart Monitor Enclosure Uninterruptible Power Supply (UPS) with 6-foot Power Cord UPS mount for Pole Cart...
Page 9: Specifications
IN-P000 REV 5 Part Quantity Image AC Mains Cable (for UPS to Monitor Enclosure power) Handpiece Handpiece Tubing Instructions for Use 1.2.5. Specifications Physical Size: Pole Cart 21” X 21” X 43”(53.3 Cm X 53.3 cm X 109.2 cm ) D X W X H 13.7”...
Page 10: Warnings
IN-P000 REV 5 Monitor Enclosure 20 lbs (9.1 kg) Service Life NTrainer™ System 2.0 is designed to provide a minimum of 3 years of service life. Uninterruptible Power Supply (UPS) Battery Type: Uninterruptible Power Supply Electrical: 550VA / 440W Capacity, 120 VAC Output, 12 V / 7 Ah Battery Isolation: Uninterruptible Power Supply provides means of isolation from supply mains.
Page 11 IN-P000 REV 5 Use only with Philips Soothie Pacifiers. Use of unapproved pacifiers may result in ineffective treatment or patient injury. o Approved Philips Soothies Pacifiers include:  NICU Soothie pacifier, notched, natural scent  Soothie Pacifier, natural scent  Wee Soothie Pacifier, notched, natural scent Do not stand or ride on the pole cart.
Page 12: Precautions
IN-P000 REV 5 1.4. Precautions Rx Only. Federal law (USA) restricts this device to sale by or on the order of a licensed physician This Instructions for Use contains the recommended procedures for preparing and using the NTrainer™ System 2.0. It is intended for physicians and other healthcare professionals who will use this device and contains pertinent information on the handling of the device.
Page 13 IN-P000 REV 5 System should only be used in a non-condensing environment. System not for use with flammable agents. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Page 14: Notes
IN-P000 REV 5 1.5. Notes NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services.
Page 15: Section 2: Operation
IN-P000 REV 5 2. Section 2: Operation 2.1. Device Parts Monitor Enclosure a. Power Button b. Handpiece Tubing Connection c. Monitor Housing Handpiece a. Patient Receiver Tube b. Start/Pause Button c. Soothie Pacifier d. Handpiece Tubing Connection Pole Cart a. Mounting Plate for Monitor Enclosure b.
Page 16: Screens Guide
IN-P000 REV 5 2.2. Screens Guide 2.2.1. Home Screen Settings Icon Assessment & Therapy Tab Manage NTrainer a. Run an Assessment Session o Manage Users b. Run a Therapy Session Add New User  Edit User  Data Overview Tab Remove User ...
Page 17: Getting Started
IN-P000 REV 5 2.3. Getting Started 2.3.1. Power On the System The NTrainer™ System 2.0 should be plugged in at all times during use and storage. It can be unplugged during transport between storage space and patient bedsides. 2.3.2. User Log In...
Page 18: Pair The Handpiece
IN-P000 REV 5 2.3.3. Pair the Handpiece...
Page 19: Set Up System Users
IN-P000 REV 5 2.3.4. Set Up System Users • System Users must be hospital clinicians or staff members, not parents/caregivers. • Patient information stored on the NTrainer™ System 2.0 is private, personally identifiable information subject to USA Federal HIPAA safeguards. This law requires access to the NTrainer™ System 2.0 be controlled by password protected user accounts.
Page 20: Set Date And Time
IN-P000 REV 5 2.3.5. Set Date and Time 2.3.6. Return to Home Screen 2.3.7. Adjust Screen Brightness...
Page 21: Adjust Volume
IN-P000 REV 5 2.3.8. Adjust Volume 2.3.9. Adjust Screen Tilt...
Page 22: User Access Guide
IN-P000 REV 5 2.4. User Access Guide The system has two types of users: a system administrator and a clinician. While both roles can access patient files only an administrator role can access certain system settings. 2.4.1. Feature Access Breakdown Function Details Role...
Page 23: Patient Files
IN-P000 REV 5 Function Details Role Administrator Clinician • Add Patient ID, Patient Name, Date of Birth, Gestational Create New Patient Age at Birth, Birth Weight and Sex • Search existing patient by first or last name or by patient Sign in Existing Patient •...
Page 24: Open An Existing Patient File
IN-P000 REV 5 2.5.2. Open an Existing Patient File 2.5.3. Edit Patient File...
Page 25: Switch Patient Files
IN-P000 REV 5 2.5.4. Switch Patient Files 2.5.5. Mark Patient as Inactive Note: Marking a patient as Inactive will remove them from the search list, but all their information will still be saved on the system.
Page 26: Set Up The Handpiece For Use
IN-P000 REV 5 2.6. Set Up the Handpiece for Use • WARNING: The Patient Receiver Tube and Soothie Pacifier are single patient use. Change Patient Receiver Tube and Pacifer, and switch to clean gloves before using the Handpiece on another patient. •...
Page 27: Supporting The Infant Before, During And After An Assessment Or Therapy Session
IN-P000 REV 5 2.7. Supporting the Infant Before, During and After an Assessment or Therapy Session The infant’s interaction with the NTrainer™ System 2.0 is designed to be a positive pleasurable developmental experience. The ideal state for learning is when the infant is calm, awake, and alert. Be aware of external environmental stimuli which will negatively impact the experience.
Page 28: Run An Assessment
IN-P000 REV 5 2.8. Run an Assessment • Objectively captures full oral motor NNS skill data • Infant’s interactions with a neutral pacifier are recorded, and displayed in graph form • Measures infant’s NNS skill development over time • Contributes to feeding readiness and advancement decisions •...
Page 29: Run A Therapy
IN-P000 REV 5 2.9. Run a Therapy • Neuromuscular intervention to strengthen and organize NNS skills • Impacts neurological pathways for oral muscular activity • Provides consistent oral stimulation via a proven pulse pattern, contracting 6 times followed by a 2-second pause, designed to mimic healthy NNS •...
Page 30 IN-P000 REV 5...
Page 31 IN-P000 REV 5...
Page 32: Data Overview
IN-P000 REV 5 2.10. Data Overview 2.10.1. View Data 2.10.2. View Multiple Assessments...
Page 33: Access A Utilization Report
IN-P000 REV 5 2.11. Access a Utilization Report 2.12. User Log Out Always Log Out between patients to ensure patient confidentiality and to prevent non-users access to protected health information. Do not leave patient screen visible in public areas.
Page 34: System Power Off
IN-P000 REV 5 2.13. System Power Off 2.14. Administrator Accessible Settings 2.14.1. Add a New System User See Section 2.3.4 – Set Up System Users 2.14.2. Edit System Users...
Page 35: Remove System Users
IN-P000 REV 5 2.14.3. Remove System Users...
Page 36: Change The Date And Time
IN-P000 REV 5 2.14.4. Change the Date and Time See Section 2.3.5 - Set Date and Time 2.15. Reset Password...
Page 37: Section 3: Care And Maintenance
The NTrainer™ System 2.0 should be inspected for signs of damage prior to every use. If signs of damage are observed, contact Cardinal Health Customer Service. The NTrainer™ System 2.0 has no serviceable parts. Internal batteries in the UPS not intended to be replaced over the life cycle of the system. Periodically inspect all fasteners associated with each part of the Pole Cart Assembly.
Page 38 IN-P000 REV 5 Caution: Disconnect Power Cord from power source before cleaning. After cleaning, do not re-connect to power source until the Monitor Enclousure, AC Mains Cable and Power Cord are thoroughly dry. Cleaning of the Pole Cart Assembly, in which the NTrainer™ System 2.0 attaches to, must be performed as follows: •...
Page 39: Troubleshooting
Unable to Log In Incorrect Password Contact System Admin for a Password Change. Incorrect Username Contact System Admin for a Username Change. Exits Therapy Unexpectedly Damage to Internal Pump Contact Cardinal Health Customer Service.
Page 40: Error Messages
3.4. Return or Disposal Procedure Return Procedure Should a malfunction occur, contact Cardinal Health Customer Service. If Cardinal Health determines that the NTrainer™ System 2.0 should be returned, you will be assigned a return authorization number and be provided shipping instructions.
Page 41: Symbols Glossary
IN-P000 REV 5 3.5. Symbols Glossary Symbol Symbol Title Explanatory Text Manufacturer Indicates the medical device manufacturer. ISO 7000-3082 Catalogue Number Indicates the manufacturer’s catalogue number so that the medical device can be identified. ISO 7000-2493 Serial Number Indicates the manufacturer’s serial number so that a specific medical device can be identified.
Page 42 IN-P000 REV 5 Symbol Symbol Title Explanatory Text Keep away from Indicates a device that needs protection from light direct sunlight sources. ISO 7000-0624 Humidity Limitation Indicates the range of humidity to which the medical device can be safely exposed. ISO 7000-2620 Operating Indicates the temperature limits to which the...
Page 43 IN-P000 REV 5 Symbol Symbol Title Explanatory Text Refer to instruction To signify that the instruction manual/booklet must manual/booklet be read. ISO 7010-M002 Refer to Operating To signify that the operating instructions must be Instructions read. ISO 7000-1641 Type B Applied To identify a type B applied part complying with IEC 60601-1.
Page 44 IN-P000 REV 5 Symbol Symbol Title Explanatory Text Alternating current Indicates that the equipment is to be powered by alternatic current. IEC 60417-5032 Non-sterile Indicates a device that has not been subjected to a sterilization process Dispose of as Indicates the product should be separately collected Electrical or and not disposed of as unsorted municipal waste.
Page 45 IN-P000 REV 5 Symbol Symbol Title Explanatory Text Non-ionizing Non-ionizing electromagnetic radiation Electronic Radiation Not Made with DEHP Indicates product does not contain PHT / DEHP. Not Made with Indicates product does not contain natural rubber Natural Rubber Latex latex. FCC Mark Indicates the device has received a FCC grant of certification.
Page 46: Cybersecurity
Never share device log-in information, leave the device logged-in or trust an unauthorized USB. If you see any suspicious behavior or have any additional questions pertaining to cyber security measures put into place for the NTrainer™ System 2.0, contact Cardinal Health Customer Service. Website: cardinalhealth.com...
Page 47: Section 4: Unboxing And Assembly
IN-P000 REV 5 4. Section 4: Unboxing and Assembly 4.1. Packaging Breakdown Quantities in boxes may vary depending on purchase order. All quantities shown here are to represent assembly only. Box 1 – REF: IN-5000 – Includes: • 1 Monitor Enclosure •...
Page 48: Cart Assembly Instructions
IN-P000 REV 5 4.2.1. Cart Assembly Instructions Quantities in boxes may vary depending on purchase order. All quantities shown here are to represent assembly only. Tools Required: 5/32'' [4 mm] Hex Wrench 2.5 mm Hex Wrench Tools Not Required: Phillips Screwdriver 1/2'' [13mm] Wrench Manufacturer Part #: GCX: RS-0006-64 Innara Health Part #: IN-5006...
Page 49 IN-P000 REV 5 4.2.1.1. Assembling Pole Cart Wheel Locks Pole Cart post Pole Cart base 5/16 Flat Washer (1) 5/16 Split Lock Washer (1) 5/16-18 X 1” HHCS (1) Step 1: Insert Pole Cart Post [1] into center of Base [2]. Step 2: Lay assembly on its side for access to bottom of Base [2].
Page 50 IN-P000 REV 5 4.2.1.2. Installing Utility Basket on Post Step 1: Install Nylon Clips [7] at an angle, in center of basket Step 3: Slide end of Post [1] through Nylon Clips [7]. Position [6] above the Reinforcing Bar. Basket [6] in middle of Pole. Rienforcing Bar Step 2: Rotate Nylon Clips [7] until both are horizontal.
Page 51 IN-P000 REV 5 4.2.1.3. Installing Mounting Plate on Pole Cart Step 1: Insert Mounting Plate [9] on top of Post [1]. Step 3: Swivel the Mounting Plate [9] until the spring-loaded plunger is toward the back of the Pole Cart [1]. Mounting Plate Step 2: Press downward while twisting until the Mounting Plate [9] snaps into place.
Page 52 IN-P000 REV 5 4.2.1.4. Adjusting Swivel and Tilt Angle of Mounting Plate Tilt Tension Adjustment Swivel Tension Adjustment Adjust Tilt tension by tightening or loosening the Adjust Swivel tension by tightening or loosening the socket set screw on the top of the Pole Cart Post. A socket set screw on the back of the Pole Cart Post.
Page 53 IN-P000 REV 5 4.2.1.5. Attaching the Pole Cart Handle Step 1: Fasten Handle [8] to Pole Cart Post [1] with two Step 2: Alternately tighten Handle screws until Handle (2) #10-32 x 9/16'' PHMS [15] as shown. does not rotate around Post. #10-32 x 9/16”...
Page 54 IN-P000 REV 5 4.2.1.6. Attaching Cable Clips Place loose cables inside Cable Clip [10] and slide the Clip onto Post [1] as shown.
Page 55: Assembling Ups Mount
IN-P000 REV 5 4.2.2. Assembling UPS Mount Note: UPS Mount is secured to top support of Box 1 – REF: IN-5000. Manufacturer Part #: GCX: RS-0024-02C Innara Health Part #: IN-2048 Tools Required: 3/16” hex wrench Item # Description Detachable Post Arm Side Clamp ¼-20 x 3/4'' SHCS #10-16 X 2”...
Page 56 IN-P000 REV 5 4.2.2.1. Installing UPS Mount Step 1: Remove Detachable Post Arm [16] from subassembly by unscrewing (2) ¼-20 x 3/4'' SHCS [18] using the 3/16” hex wrench [20]. Step 2: Reassemble the Detachable Post Arm [16] around the post of the Pole Cart [1], at a height of no more than 6 inches from the Poll Cart base.
Page 57: Mounting Ups
IN-P000 REV 5 4.2.3. Mounting UPS Manufacturer Part M550L Innara Health Part #: IN-5005 Step 2: Attach it to the center-bottom rim of Step 1: Remove one side of the Velcro Strip Pair [21] from the UPS so that it lines up with the Velcro Strip UPS Mount.
Page 58 IN-P000 REV 5 Step 4: Slide Side Clamp towards post until it Step 5: Twist #10-16 X 2” OHSMS with hand into securely hugs UPS. track. NOTE: Adjustment Screws must always be engaged at least ½” in the track at all times. For more information on the UPS use and operation go to www.cyberpower.com or follow the QR code...
Page 59: Assembling Monitor Enclosure
IN-P000 REV 5 4.2.4. Assembling Monitor Enclosure Item # Description Monitor Enclosure Handpiece Tubing Handpiece Patient Consumable/ Receiver Tube Phillips Soothie Pacifier 1 Handpiece Holders AC Mains Cable for UPS to Monitor power (boxed with UPS) 4.2.4.1. Mounting Monitor Enclosure Step 1: Ensure plastic screws on the front of the Mounting Plate are loosened.
Page 60 IN-P000 REV 5 Step 2: Pull plunger down as you slide the Monitor Enclosure onto the Mounting Plate. WARNING: Dropping the Monitor Enclosure during assembly or servicing may cause bodily harm. Plunger...
Page 61: Connecting The System
IN-P000 REV 5 4.2.4.2. Connecting the System Step 1: Plug one end of the AC Mains Cable [28] to the back of the Monitor Enclosure [22]. Step 2: Wrap AC Mains Cable [28] down the Pole Cart Post [1], using the Cable Clips [10] to secure in place. Cable Clips...
Page 62 IN-P000 REV 5 Step 3: Plug other end of the AC Mains Cable [28] into the UPS System. Ensure the 6-foot Power Cord is plugged into the wall prior to use. CAUTION: Inspect the 6-foot Power Cord for damage or wear prior to use.
Page 63: Assembled Unit
© 2023 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, INNARA HEALTH, the Innara Health LOGO, NTRAINER and NTRAINER SYSTEM are trademarks of Cardinal Health and may be registered in the US and/or in other countries. All other trademarks are the property of their respective owners. Patent cardinalhealth.com/patents.

This manual is also suitable for:

In-5000 In-5001 In-5002 In-5005 In-5006