Product Specifications

N9+ Device

SafetyComplies withIEC 60601-1, IEC 60601-1-2,
IEC 60601-1-11, IEC 62471,
ISO 80601-2-61, IEC 60601-2-18
ClassificationAnti-electric Shock TypeInternally powered equipment.
Anti-electric Shock DegreeType BF equipment
Degree of Protection against Harmful Ingress of WaterIP22 - Protection against falling drops of water when unit is tilted 15o.
Applied PartsN9+ device, N9+ wireless otoscope and accessories.
Physical CharacteristicsDevice sizeWidth 57.5mm/2.26inch Height 174mm/6.85 inch
Device weight133 Grams (6.49 Ounces)
Operating EnvironmentTemperatureFrom 41°F up to 104°F
From 5°C up to 40°C
HumidityFrom 5% up to 95% RH (non- condensing)
Storage/ Transport EnvironmentTemperatureFrom -13°F up to 158°F From -25°C up to 70°C
HumidityFrom 5% up to 95% (non- condensing)
Atmospheric Pressure50 kPa to 106 kPa
MaterialsBiocompatibilityContact parts were tested to comply with biocompatibility following ISO 10993-1.
Service Life5 years
StethoscopeMeasurement SiteOn the body
Pickup sensorMicrophone (26- dBFS sensitivity)
Sound ProcessingDigital signal processing
Frequency ResponseRange 1: 20 – 200 Hz
Range 2: 100 - 500 Hz
Range 3: 50 - 500 Hz
Range 4: 30 - 350 Hz
AmplificationAutomatic Gain Control (AGC), limited to x27852
ThermometerPrinciple of OperationInfrared thermometer that converts the patient
forehead temperature to an
oral equivalent temperature.
Measurement SiteForehead skin, display oral- equivalent
Temperature Measurement Range32.2 ºC – 43.3 ºC (90.0 ºF –
109.9 ºF)
Temperature Resolution0.1 ºC (±0.1 ºF)
Temperature Accuracy (*)±0.2 ºC (±0.4 ºF) for 35 ºC –
42 ºC (90.0 ºF – 109.9 ºF);
±0.3 ºC (±0.5 ºF) for below
34.9 ºC or above 42.1 ºC
Measurements displayCelsius / Fahrenheit Switchable
Pulse OximeterMeasurement SiteFingertip
Measurement TypeSpot measurement
LED WavelengthRed - 660 nm Infrared - 880nm
Measurement Range
SpO2 Accuracy70-100%: ±2%
0-69%: unspecified
SpO2 Resolution1%
Pulse Rate Measuring Range30 to 250 BPM
Pulse Rate Accuracy±3 BPM
Pulse Rate Resolution1 BPM
Power SourceTwo 1.5V AAA Alkaline batteriesPower Source
Intended patient populationAdults and pediatricIntended patient population
Frequency Band of Transmission2.4 – 2.5 GHzChannels (2MHZ spacing)
Frequency Characteristics of the ModulationGFSK
Modulation10 dBm
Maximum RF Input Typical Receive Sensitivity-95 dBm
Maximum RF Tx Output Power12 dBm

N9+ Wireless Otoscope

Weight24.3g (0.9 ounces)
Operating FrequencyWIFI 2.4GHz
Gyroscope3 axis
Network standardIEEE802.1 1b/g/n
AntennaInternal FPC
Image transition rate20 fps
Waterproof & Dustproof ClassificationIP22
Duration of Continuous Use (full charge)Approx. 85 min
Battery300mAh lithium battery
Charging time85 min
Input voltageDC 5V, 0.5A
Lens diameter3.5 mm
Field of view angle73°


The N9+ system is initially calibrated at the time of manufacture. If this system is used according to the use instructions, periodic readjustment is not required.
Note: A functional tester cannot be used to assess the accuracy of the Pulse Oximeter. The Pulse Oximeter function can only be assessed through clinical trials.

N9+ Device Symbols

Prescription device (only for the pulse oximeter)
Date of Manufacture
Serial Number
IP22Protected from ingress of foreign objects the size of a finger, and from dripping when tilted 15 degrees.
Caution - Consult Accompanying Documents
Type BF applied part (Degree and type of protection against electric shock)
Caution - Refer to instruction manual/ booklet
Equipment should not be disposed of in the normal waste stream
AAA 1.5VInput Voltage
FCC ID of the Bluetooth Module used
FCC ID of the wireless otoscope
Keep Away from Sunlight
Temperature Limit
Humidity Limitation
Atmospheric Pressure Limitation
Part number
Lot number
Non sterile
Remaining battery
Contains FCC ID: Z64-2564N
This system complies with Part 15 of FCC Rules. Operation is subject to the following two conditions:
(1) This system may not cause harmful interference, and (2) this system must accept any interference received, including interference that may cause undesired operation.

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