NightOwl® Sensor Healthcare Professional Manual Instructions for Use – NightOwl® Sensor – Healthcare Professional Page 1 of 24
1 Document information These instructions for use were developed exclusively for the healthcare professional (‘HCP’) and shall not serve to inform patients on their usage of the NightOwl® Sensor.
2.2 Commercial support Choose to contact Commercial Support over Technical Support for any questions related to warranty or replacement programs, pricing, or adaptations of documentation according to your specific clinical pathway. 2.2.1 Product sourced from Ectosense In case your product was purchased directly from Ectosense, follow the steps outlined under 2.1 Technical support. 2.2.
1 2 3 4 5 6 7 8 Table of Contents Document information Contacting us 2.1 Technical support 2.2 Commercial support 2.2.1 Product sourced from Ectosense 2.2.2 Product sourced from distributors Introduction 3.1 Intended use 3.2 Intended use cases 3.3 Claims 3.4 Connection to the NightOwl® Diagnostic System 3.4.1 NightOwl® Companion app 3.4.2 NightOwl® Software algorithms 3.4.3 Ectosense Healthcare Professional app 3.4.4 Ectosense Dashboard 3.5 Intended Application 3.6 Contra-indications 3.6.1 General 3.
9 8.1 Device and accessories 8.2 Disposal 8.3 Symbols used on the product labels Warranty and replacement 9.1 Limited Warranty 9.2 Outside warranty replacements 9.2.1 Lost sensor or charging cradle 9.2.
3 Introduction The NightOwl® Sensor is a wireless device designed for comfortable, continuous data recording during an individual’s sleep. The device records two signals: Dual-wavelength photoplethysmography (“PPG”), from which oxygen saturation, peripheral arterial tone (PAT), and pulse rate channels can be derived. 3-axis accelerometry to capture motion-based activity from which total sleep time (“TST”) and body position can be derived (depending on the sensor’s placement).
3.4 Connection to the NightOwl® Diagnostic System Ectosense’s software tools enable the automated analysis to support healthcare professionals in the diagnosis and monitoring of patients for sleep apnea, as well as provide means to set-up, manage, and track these patients. Together, these tools constitute the NightOwl® Diagnostic System. The NightOwl® Sensor can be used as part of that system, although it is a medical device on its own and available for other uses as well.
3.4.1 NightOwl® Companion app Description: iOS and Android smartphone application available for download in the respective app stores Intended User: patients Intended Use: Links patient with the test provider and test configuration by means of a code or unique link Provides patient with instruction for set-up Receives data over Bluetooth® Low Energy (BLE) from the NightOwl® Sensor, and sends it to the NightOwl® Software's cloud environment Optional: Push questionnaires to patients 3.4.
Intended Use: Initiate testing and configure tests Inspect status of tests and final diagnostic reports Optional: Order logistical fulfilment by Ectosense Admins only: Oversee billing and enrollment of related healthcare professionals into a joint working unit 3.5 Intended Application The device is intended to be in contact with non-injured skin at the following body site(s): The distal phalanges (fingertip) Body application can last for 15 hours or more and application can be repeated daily.
Always transport and store the sensor, charging cradle, power plug, or charging cable in the original packaging to ensure that no damage to the components may arise during transportation and storage. The finger wrap for adhesion of the sensor should be disposed of after each use. 3.7.2 Warnings A warning alerts you to possible injury. Choking hazard! Keep the device and its accessories away from children.
4. Disposable finger wraps (single-use) 5. Charging cable (USB-A to USB-C) to connect the charging cradle with the power plug; 6. Power plug with USB-A port (optional, depending on your geography). Do not use the Sensor with accessories that are not expressly indicated by Ectosense as fit for use as this may cause damage, injuries, loss of performance, and voidance of the warranty. In particular, pay attention not to use the charging cradle with a power plug that does not output 5 VDC 700mA nominal, 1A max.
In Offline Mode, memory is constrained to 30 hours of recording. After 10 hours, the sensor will automatically turn off to preserve memory. Upon reaching full memory, the sensor will overwrite the oldest recording present on the memory. NightOwl® Diagnostic System Ectosense makes available the Ectosense Healthcare Professional app to download the data off the Sensor over a BLE 5 connection using an Android smartphone or tablet. This app also allows to associate the sensor with a patient.
5.2 Recording configuration and association The configuration of recordings and associating the sensor with a patient or test is optional and takes place within the NightOwl® Diagnostic System. NightOwl® Diagnostic System Healthcare professionals can use the Ectosense Dashboard to create a test and input patient details, or leave it to the patient to input further details in the NightOwl® Companion app.
5.3 Device set-up 3. Turn on the sensor. 4. Place the sensor with the white side up. 5. Take a new adhesive and remove its top liner on the round sided end. 6. Adhere the round, sticky side of the adhesive on top of the white side of the sensor 8. Remove the second part of the liner 9. If the wrap breaks or gets damaged during the application, just take a new one. 1. Place the finger on the green side of the sensor. Make sure the finger is aligned with the sensor and it rests flat on the sensor. 2.
10.The sensor is now correctly applied. NightOwl® Diagnostic System Online Mode Patients using the Online Mode will be guided through extensive instruction videos on the smartphone application which introduce all the above-mentioned steps. Ectosense also provides paper-based Step-by-Step Instructions (Online Mode) that can be further tailored to your process and pathway and can aid in explaining the test to your patients (see example to the right).
5.4 Data retrieval Recordings performed in the Online Mode do not require further data retrieval. Recordings performed in the Offline Mode are stored internally on the sensor and require further data retrieval. This data download is to be performed over BLE and requires a qualified smartphone or tablet app. Whether data is still present on the sensor can be checked by turning the device on: if a short green light does not immediately appear, data is still available for downloading.
5.5.2 How to recharge the sensor The power plug is designed to be used within 110-240V AC, 50-60Hz. Check if the required voltage is available before connecting the adapter to the socket. Failure to do so can lead to damage to the sensor, charging cradle, power plug, or charging cable. The sensor can only be charged using the supplied wireless charging cradle. To bring a depleted battery up to 10 hours of usage requires approximately 60 minutes of charging.
It is recommended to subject the sensor to cleaning as described above in between use by different patients. Recommend patients to perform such cleaning at home when the sensor remains with them for an extended period of time. 6.2 Disinfecting After cleaning the sensor as instructed above, disinfect the device as follows: 1. 2. 3. 4. Apply undiluted disinfectant to a clean non-dyed disposable cloth. Wipe all surfaces of the sensor. Leave the disinfectant on the sensor for five minutes.
7 Troubleshooting 7.1 Indicator lights under normal usage Indicator light Online Mode Purple blinking Blue 2 seconds Blue blinking Offline Mode Green 0.5 second flash Green blinking Meaning The battery is too low – recharge the sensor. A connection with a qualified smartphone app was established successfully. The sensor was previously connected to an app, and has now lost connection. It is possible that you moved too far away from the smartphone.
defective warranty term, or Commercial Support when outside of it. My sensor is heating while charging, resulting in the sensor having an uncomfortable temperature 1. Remove the sensor from the charging cradle and abstain from using the sensor. 2. Report the issue to Technical Support. The sensor vibrates when turning on, but the Optical Module does not start to emit light 1. 2. After sensor application, the user’s skin has become irritated. 1. Abstain from further using the sensor. 2.
8 Technical Specifications 8.1 Device and accessories Signals and samples rates Photoplethysmography of wavelengths 660nm (red) and 880nm (infrared) at 50 Hz. Accelerometry at 25 Hz. Recording time 30 hours (3 x 10 hours) Power supply Rechargeable lithium-ion battery (graphite layered metal oxide LiNixMnyCozO2), 3.7V, 60mAh, cycle life (80%) >500. UN 38.3, UL 1642, IEC 62133 passed.
2. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
8.3 Symbols used on the product labels CE labelling in accordance with EC Directive 93/42/EEC, Class I Manufacturer WEEE Directive 2012/19/EU concerning waste electrical and electronic equipment (EEE). See 8.2 Disposal. Serial number 9 Warranty and replacement 9.1 Limited Warranty If you have contracted directly with Ectosense nv, Belgium, you have been supplied Sales Conditions that specify the warranty and shall supersede what follows.
Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you. 9.2 Outside warranty replacements 9.2.1 Lost sensor or charging cradle Ectosense or its distributors offer a lost devices program that allows operators to acquire a replacement sensor or charging cradle at a significantly reduced cost in the following geographies: United States Contact Commercial Support for further information (see 2 Contacting us). 9.2.
