ndd EasyOne Sky Wireless Bluetooth Spirometer with Buddy Coach

EasyOne Sky Spirometer: Wireless, Cloud-Connected, Coached by Buddy

The EasyOne Sky is ndd's next-generation handheld spirometer, a wireless, calibration-free device that pairs over Bluetooth Low Energy to a Windows PC running the EasyOne Mobile application. Guided by Buddy, ndd's built-in spirometry coach, patients perform maneuvers with real-time on-screen feedback while clinicians get ATS/ERS 2019 quality grading and ATS/ERS 2022 interpretation automatically. Every test routes securely to nddCloud, ndd's HITRUST-certified backend, for backup, multi-user access, and optional EMR/EHR integration.

Meet Buddy: Your Built-in Spirometry Coach

Demonstrates the maneuver to the patient before testing
Guides patients through each forced expiratory effort
Provides real-time, intuitive feedback to improve effort quality
Reduces operator workload and patient anxiety for more reliable results

Ultra-Portable Wireless Design

Just 4.9 oz (140 g) without batteries — 4.3 x 3.3 x 1.3 in (111 x 84 x 33 mm)
Runs on 2 standard AA batteries — no charging cradle, no proprietary battery
Bluetooth Low Energy v5.1 connection to Windows laptop or desktop
Type BF applied part, classified for patients age 4 and up

TrueFlow™ Trusted Ultrasound Technology

Calibration-free with proven lifetime stability
Contact and resistance-free measurement
Outstanding accuracy and robustness
Patented Swiss precision-engineered technology

nddCloud Connectivity: HITRUST-Certified, Secure by Design

Patient data never lives on the local PC and remains encrypted in transit and at rest
Automatic cloud backup for every completed test
Authorized clinician access from any networked location
Centralized data across all sites and users in your practice
3 years of nddCloud access included. Subscription renewal and multi-site (nddHub Fleet Management System) options are handled directly through ndd.

EMR/EHR Integration

Integrates with all major EMR/EHR systems via HL7 or REST API
Bidirectional order-to-result workflow supported
EMR setup and ongoing maintenance available with Subscription tier

QC-Grading and Result Interpretation

Automatic quality grading based on ATS/ERS 2019
Automatic interpretation per ERS/ATS 2022
GOLD/Hardie interpretation supported
Reference values: Global GLI (Bowerman) 2023, GLI (Quanjer) 2012, NHANES III (Hankinson) 1999

Compliance and Clearances

Full compliance with ATS/ERS 2019 spirometry standards
US FDA 510(k) cleared
EU MDR 2017/745 / CE approved
ISO 13485, ISO 14971, IEC 60601-1 / 60601-1-2, IEC 62366-1

Product Brochures

EasyOne Sky Spirometer Ships With:

EasyOne Sky Spirometer
2 x AA Batteries
EasyOne FlowTube mouthpieces (starter quantity)
Bluetooth Low Energy dongle
Quick Start Guide
3 years nddCloud access
3-year warranty

Compatible Accessories

ndd EasyOne® Sky Spirometer Specifications

Technical
Data management	EasyOne Mobile (Windows desktop application)
Cloud platform	nddCloud (HITRUST-certified)
EMR/EHR export	HL7, REST API (via nddCloud)
Data link	Bluetooth® Low Energy v5.1 and higher (BLE dongle included)
App compatibility	Windows 10/11
PC hardware (recommended)	AMD/Intel 4+ cores (e.g. Intel i5-12400), 16+ GB RAM, SSD with ≥10% free, 1920 x 1080 display, broadband internet
Age range	Spirometry > 4 years
Dimensions	111 x 84 x 33 mm (L x H x W) 4.3 x 3.3 x 1.3 in
Weight	140 g / 4.9 oz (without batteries)
Device classification	Type BF applied part
Operating conditions	Temp 5 - 40 °C / 41 - 104 °F Rel. Humidity 15 - 90% (non-condensing) Atmospheric Pressure 700 - 1060 hPa
Power supply	2 x AA batteries (0.3 W power consumption)
Warranty	3 years
Tests & Parameters
FVC	BEV, FEF25, FEF25-75, FEF50, FEF75, FET, FEV.75, FEV.75/FVC, FEV1, FEV1/FVC, FEV1Q, FVC, PEF *shown for children <6 yr
FVL	BEV, FEF25, FEF25-75, FEF50, FEF75, FET, FEV.75, FEV.75/FVC, FEV1, FEV1/FVC, FEV1Q, FIVC, FVC, PEF, PIF *shown for children <6 yr
Post Bronchodilator	FVC %change, FEV1 %change
Predicted Normal Values
Global	Global GLI (Bowerman) 2023
GLI	GLI (Quanjer) 2012
North America	NHANES III (Hankinson) 1999
System Interpretation & Quality Grading
Interpretation	ERS/ATS 2022, GOLD/Hardie
Quality grading	ATS/ERS 2019 (automatic)
Flow & Volume Sensor
Type	Ultrasonic transit time (TrueFlow™)
Flow Range	± 16 L/s
Flow Resolution	1 mL/s
Flow Accuracy (except PEF)	± 2% or 0.020 L/s
PEF Accuracy	± 5% or 0.2 L/s
Volume Range	± 12 L
Volume Accuracy	± 2% or 0.050 L
Resistance	< 1.5 cm H₂O/L/s at 14 L/s
Standards & Recommendations
Quality, Medical Devices & Electrical	ISO 13485, ISO 14971, IEC 62366-1, IEC 60601-1, IEC 60601-1-2, 2014/53/EU, 2012/19/EU, 2011/65/EU, 2015/863, 2006/66/EU, 2018/852
FDA	510(k) clearance
Market clearance	EU MDR 2017/745, CE approved
Associations & Institutes	ATS/ERS 2019 Spirometry Standard
Languages
English, Spanish

ndd EasyOne Sky Wireless Spirometer with Buddy Coach

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EasyOne Sky Spirometer: Wireless, Cloud-Connected, Coached by Buddy

Product Brochures

EasyOne Sky Spirometer Ships With:

Compatible Accessories

ndd EasyOne® Sky Spirometer Specifications

ndd EasyOne Sky Wireless Spirometer with Buddy Coach

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EasyOne Sky Spirometer: Wireless, Cloud-Connected, Coached by Buddy

Product Brochures

EasyOne Sky Spirometer Ships With:

Compatible Accessories

ndd EasyOne® Sky Spirometer Specifications

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