N9+ Device
| Safety | Complies with | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, ISO 80601-2-61, IEC 60601-2-18 |
| Classification | Anti-electric Shock Type | Internally powered equipment. |
| Anti-electric Shock Degree | Type BF equipment | |
| Degree of Protection against Harmful Ingress of Water | IP22 - Protection against falling drops of water when unit is tilted 15o. | |
| Applied Parts | N9+ device, N9+ wireless otoscope and accessories. | |
| Physical Characteristics | Device size | Width 57.5mm/2.26inch Height 174mm/6.85 inch |
| Device weight | 133 Grams (6.49 Ounces) | |
| Operating Environment | Temperature | From 41°F up to 104°F |
| From 5°C up to 40°C | ||
| Humidity | From 5% up to 95% RH (non- condensing) | |
| Storage/ Transport Environment | Temperature | From -13°F up to 158°F From -25°C up to 70°C |
| Humidity | From 5% up to 95% (non- condensing) | |
| Atmospheric Pressure | 50 kPa to 106 kPa | |
| Materials | Biocompatibility | Contact parts were tested to comply with biocompatibility following ISO 10993-1. |
| Service Life | 5 years | |
| Stethoscope | Measurement Site | On the body |
| Pickup sensor | Microphone (26- dBFS sensitivity) | |
| Sound Processing | Digital signal processing | |
| Frequency Response | Range 1: 20 – 200 Hz | |
| Range 2: 100 - 500 Hz | ||
| Range 3: 50 - 500 Hz | ||
| Range 4: 30 - 350 Hz | ||
| Amplification | Automatic Gain Control (AGC), limited to x27852 | |
| Thermometer | Principle of Operation | Infrared thermometer that converts the patient |
| forehead temperature to an | ||
| oral equivalent temperature. | ||
| Measurement Site | Forehead skin, display oral- equivalent | |
| Temperature Measurement Range | 32.2 ºC – 43.3 ºC (90.0 ºF – | |
| 109.9 ºF) | ||
| Temperature Resolution | 0.1 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 display | Celsius / Fahrenheit Switchable | |
| Pulse Oximeter | Measurement Site | Fingertip |
| Measurement Type | Spot measurement | |
| LED Wavelength | Red - 660 nm Infrared - 880nm | |
| SpO2 | 40-100% | |
| Measurement Range | ||
| SpO2 Accuracy | 70-100%: ±2% | |
| 0-69%: unspecified | ||
| SpO2 Resolution | 1% | |
| Pulse Rate Measuring Range | 30 to 250 BPM | |
| Pulse Rate Accuracy | ±3 BPM | |
| Pulse Rate Resolution | 1 BPM | |
| Power Source | Two 1.5V AAA Alkaline batteries | Power Source |
| Intended patient population | Adults and pediatric | Intended patient population |
| BLUETOOTH specification | Frequency Band of Transmission | 2.4 – 2.5 GHzChannels (2MHZ spacing) |
| Frequency Characteristics of the Modulation | GFSK | |
| Modulation | 10 dBm | |
| Maximum RF Input Typical Receive Sensitivity | -95 dBm | |
| Maximum RF Tx Output Power | 12 dBm | |
N9+ Wireless Otoscope
| Weight | 24.3g (0.9 ounces) |
|---|---|
| Size | 140x14mm |
| Operating Frequency | WIFI 2.4GHz |
| Gyroscope | 3 axis |
| Resolution | 5MP |
| Network standard | IEEE802.1 1b/g/n |
| Antenna | Internal FPC |
| Image transition rate | 20 fps |
| Waterproof & Dustproof Classification | IP22 |
| Duration of Continuous Use (full charge) | Approx. 85 min |
| Battery | 300mAh lithium battery |
| Charging time | 85 min |
| Input voltage | DC 5V, 0.5A |
| Lens diameter | 3.5 mm |
| Field of view angle | 73° |
Calibration
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
| Rx only | Prescription device (only for the pulse oximeter) |
 | Manufacturer |
 | Date of Manufacture |
 | Serial Number |
| IP22 | Protected 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 |
 | Bluetooth |
 | Equipment should not be disposed of in the normal waste stream |
| AAA 1.5V | Input Voltage |
| FCC ID: Z64-2564N | FCC ID of the Bluetooth Module used |
| FCC ID: 2AU63-P30 | FCC ID of the wireless otoscope |
 | Keep Away from Sunlight |
 | Temperature Limit |
 | Humidity Limitation |
 | Atmospheric Pressure Limitation |
 | Part number |
 | Lot number |
 | Non sterile |
 | Wi-Fi |
 | 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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