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Summary of Contents for Nidek Medical Nano
- Page 1 Nano PORTABLE OXYGEN CONCENTRATOR INSTRUCTIONS FOR USE For Nuvo Nano, model 855 (and variants thereof) [Original language is English] 2010-8101CE-B December 2019...
- Page 2 2010-8101CE-B December 2019...
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Page 3: Table Of Contents
TABLE OF CONTENTS 1 SYMBOLS .................... 4 2 GENERAL WARNINGS AND PRECAUTIONS ......... 6 3 CONTRAINDICATIONS ................ 7 4 YOUR DEVICE ..................8 4.1 INTENDED USE AND OPERATION ..........8 4.2 DEVICE FEATURES ................ 9 4.3 POWER SUPPLY ................10 4.4 HUMAN MACHINE INTERFACE (HMI) ......... -
Page 4: Symbols
1 SYMBOLS These symbols are found in this Instructions for Use (IFU), on the device and shipping cartons, and on the device labels. Symbol Meaning WARNING – A hazard or unsafe practice that can result in serious injury or death if conditions are not avoided. CAUTION - A hazard or unsafe practice that can result in minor injury and / or property damage if conditions are not avoided. - Page 5 SYMBOLS (CONT.) Tools Required / Technician Only Do Not Dispose of as Unsorted Municipal Waste Keep in Dry conditions Direct Current (DC) Date of Manufacture Job Number (Lot / Batch number) Serial Number Catalog Number (Model number plus variant) Refer to Technical Information / Service Manual Refer to Instructions for Use / User’s Guide Keep in Vertical Position FRAGILE –...
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Page 6: General Warnings And Precautions
The settings of the Nano might not correspond with continuous flow oxygen. The settings of the Nano do not correspond with other WARNING brands or models of oxygen concentrators. Please see the specifications on pg 18 to determine your setting. -
Page 7: Contraindications
GENERAL WARNINGS AND PRECAUTIONS (CONT.) Only persons who have read and understood this entire WARNING manual should be allowed to operate the device. ℞ Federal Law (US) restricts this device to sale by, or on the order of, a licensed physician. This oxygen concentrator Only should be used only under the supervision of a licensed physician. -
Page 8: Your Device
(hypoxaemia). The Nano is small, portable and may be used in home, institution and various mobile environments. To ensure your safety, use only after one or more settings... -
Page 9: Device Features
4.2 DEVICE FEATURES Front panel (Fig. 1) 1 – Human Machine Interface (HMI) 2 – Oxygen Product Outlet 3 – Cabinet Filter 4 – Air Exhaust Intake Filter not pictured – accessed after removing Cabinet Filter (Fig. 1-3) See pg. 29 for replacing. Figure 1 Rear panel (Fig. -
Page 10: Power Supply
When fully charged, the battery can serve for up to 4 hours of operation. To recharge the battery, install it in the Nano and connect the AC/DC Power Supply (below). Fully charging will take no more than 4 hours. -
Page 11: Human Machine Interface (Hmi)
4.4 HUMAN MACHINE INTERFACE (HMI) Symbol Operation Meaning - Press once to turn “ON” On / Off - Press and hold for one second to turn “OFF” Press this button to toggle between the Mute Audible audible alarm being on or off. Alarms Press this button to display the information of Info /... -
Page 12: Screens
4.5 SCREENS HOME SCREEN Icon Description Flow Setting (from 1 to 5) Battery Charge Level Device Run Time (H:MM) (single use) Alerts are Muted Alerts are Audible 2010-8101CE-B December 2019 Page 12 of 36... - Page 13 SCREENS (CONT.) POWER SUPPLY SCREENS • Device is ON • Only battery attached (Power Supply not attached) • Battery level shows percentage remaining time remaining (H:MM) • Device is ON • Only battery attached (Power Supply not attached) •...
- Page 14 SCREENS (CONT.) POWER SUPPLY SCREENS (CONT.) • Device is OFF • Only Power Supply attached (No battery attached) ALARM SCREENS (See §4.5 for all active alarm messages and actions) Active Alarm in Audible Mode Absence of Breath Check Cannula Active Alarm in Mute Mode Absence of Breath Check Cannula Multiple Active Alarms...
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Page 15: Safety Features And Alarms
4.6 SAFETY FEATURES AND ALARMS SAFETY FEATURES Fire Break: This device is fitted with a metal fire break at the Oxygen Product Outlet (Fig 1-2). This break will keep fire from entering the device. Auto Pulse Mode: This mode is enabled when no breath has been detected for 15 seconds. - Page 16 SAFETY FEATURES AND ALARMS (CONT.) ACTIVE ALARM MESSAGES Message Display Explanation and Action No breath detected for more than 15 seconds. Auto pulse mode enabled. Absence of Breath Check if cannula is connected firmly, not kinked, worn Check Cannula correctly and breathing through nose. Oxygen concentration is below 87% for more than 5 Low Oxygen: <...
- Page 17 SAFETY FEATURES AND ALARMS (CONT.) Explanation and Action Message Display Sieve bed does not work or has become invalid. Sieve Bed Fail Device will shut down after 10 seconds. Contact Provider Replace Sieve bed (Contact equipment provider). System voltage is less than 10.5V. Power Supply Fail Device will shut down after 10 seconds.
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Page 18: Performance And Specifications
21°C (70°F) and one atmosphere. The specifications may change with temperature and altitude. Model Description Nuvo Nano Oxygen Concentrator Power Supply AC Input 100 to 240 VAC / 50 to 60 Hz Rechargeable Battery 14.54VDC Voltage / 6.8Ah Rated Capacity User Interface 2.8 inch large LCD color display... - Page 19 PERFORMANCE AND SPECIFICATIONS (CONT.) FLOW CONTROL SETTINGS AND PULSE VOLUMES Settings Breath Pulse Volumes (ml) Rate 66.7 10.5 31.5 16.8 25.2 33.6 33.3 28.6 10.5 15.8 ±15% at Standard Temperature and Pressure, dry (STDP)* ± 25% over the rated environmental range * STDP is 101.3kPa at an operating temperature of 20°C, dry Materials in direct or indirect contact with the patient Item...
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Page 20: Accessories And Spare Parts
FDA QSR or the 93/42/EEC European Directive, or any other applicable regulatory requirements. The accessories below, available from Nidek Medical Products, Inc. and our distributors, comply with these requirements. Contact your equipment supplier to obtain these accessories. -
Page 21: Unpacking And Inspection
5 UNPACKING AND INSPECTION The Nano is packaged to protect the device from damage while being transported and stored. After the device is removed from the package, inspect for damage. If damage is detected, please contact your equipment provider. Your package will contain the following items:... -
Page 22: Operation
Device must have power to operate. In the event of power WARNING loss and for continued operation a backup source is recommended. The Nano is designed for continuous use. For optimal life CAUTION of the sieve beds, it is recommended to operate the device frequently. -
Page 23: Travel
TRAVEL BY AIR ADDITIONAL INFORMATION The FAA allows the Nano onboard all U.S. aircraft, here are a few points to make traveling by air easy. 1) Ensure your device is clean, in good condition and free from damage or other signs of excessive wear or abuse. -
Page 24: Start Up
Blocked air circulation can cause internal heat build-up CAUTION causing the device to shut down. See §4.5 for Alarm Messages and responding actions. DO NOT operate the Nano without the cabinet filter and CAUTION intake filter. Intake of particles into the system can damage the device. - Page 25 START UP (CONT.) 4. Connect the AC Power Supply to the device. The green LED on the power supply block will be illuminated and the device will beep. DO NOT place anything in the power supply port (Fig. 3- D) other than the supplied cord. WARNING Do not place anything in the power supply input (Fig.
- Page 26 5. Attach the cannula to the oxygen outlet fitting (Fig 1-2). Ensure cannula and tubing is not kinked. 6. Turn on the Nano by quickly pressing the ON/OFF button (§4.3). The indicator light will flash and the display will show the Nidek Medical Products, Inc.
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Page 27: Shut Down
START UP (CONT.) 8. Wear the cannula on your face and breathe through your nose. If no breath is detected for 15 seconds, it will enter auto pulse mode. The device will begin to pulse automatically about once every 3 seconds until it detects a breath. -
Page 28: Troubleshooting
6.4 TROUBLESHOOTING The table below lists some common problems and actions you can take. If you can’t resolve the problem, please contact your service provider. Problem Possible Cause Recommended Solution Battery is not Remove the battery and installed correctly. reinstall. Use the AC Power Supply to operate the device (with the Battery is depleted. -
Page 29: Cleaning And Maintenance
7 CLEANING AND MAINTENANCE 7.1 CLEANING CLEANING YOUR DEVICE Only the outside of the device is to be cleaned. After making sure the device is OFF, use a soft, dry cloth or, if necessary, a damp sponge, to wipe the cabinet enclosure. To prevent the spread of bacteria and viruses, this should be done daily and for each new patient. -
Page 30: Maintenance
Use original spare parts only (see §4.8) from Nidek Medical Products, Inc. or our distributors. Upon request, the supplier can provide circuit diagrams, spare parts lists, technical details or any other information of use to qualified technical personnel for parts of the device which are designated as being the manufacturer’s responsibility or by the... - Page 31 MAINTENANCE (CONT.) EXPECTED SERVICE LIFE Service Item Expected Life Nuvo Nano System 5 years Molecular Sieve Beds 1 year Battery 500 full charge / discharge cycles The accuracy of the expected service life is dependent on the environment of usage and the preventive and required maintenance performed.
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Page 32: Disposal
Furthermore, as part of the marking directive 93/42/EEC, the serial number of the device disposed of must be sent to Nidek Medical if the unit has the marking. 2010-8101CE-B... -
Page 33: Emc Information
9 EMC INFORMATION The device has been designed to meet EMC standards throughout its service life. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions: The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. - Page 34 EMC INFORMATION (CONT.) Guidance and Manufacturer’s Declaration – Electromagnetic Emissions: The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. 2010-8101CE-B December 2019 Page 34 of 36...
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Page 35: Conformity With En 60601-1
10 CONFORMITY WITH EN 60601-1 The manufacturer, assembler, installer or distributor are not considered to be responsible themselves for the consequences on the safety, reliability and characteristics of a device unless the: • Assembly, fitting, extensions, adjustments, modifications or repairs have been performed by persons authorized by the party in question. - Page 36 Nidek Medical Products, Inc. Nidek Medical Products, Inc. 3949 Valley East Industrial Drive 3949 Valley East Industrial Drive Birmingham, Alabama 35217 U.S.A. Birmingham, Alabama 35217 U.S.A. Tel: 205-856-7200 Fax: 205-856-0533 Tel: 205-856-7200 Fax: 205-856-0533 info@nidekmedical.com www.nidekmedical.com EU Representative mdi Europa GmbH Langenhagener Str.
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