FCC ID: HFSMH7 QOCA pulse oximeter

QOCA pulse oximeter Model o2a Contents Caution and Safety Notes ........................................................................... 4 PRODUCT OVERVIEW .................................................................................. 9 Indication for Use ........................................................................... 9 Package Content ........................................................................................ 10 List .................................................................................................. 10 Product components .......................................................... 11 Product requirement ................................................................... 14 preparation .................................................................................................. 15 Measurement Start ............................................................. 16 QOCA SpO2 APP ................................................................. 19 Data transmittion ................................................................ 23 Indicator ............................................................................... 24 2 iNFORMATION ........................................................................................... 26 Clean and Preservation ....................................................... 26 Techinical data ..................................................................... 27 Trouble shouting ................................................................. 31 Signs and Symbols .............................................................. 38 3 CAUTION AND SAFETY NOTES QOCA pulse oximeter is to be used for clinical assessment only. QOCA pulse oximeter could be used by layperson. No race and skin color limited QOCA pulse oximeter consists entirely of sophisticated medical electrical parts. Maintenance can only be carried out by professional technicians. Unauthorized disassembly of the device by the user is not allowed. Do not use the device in flammable anesthetics or flammable gas environments. Do not allow the connectors or contacts on the devices to come into contact with any kind of power source during use. Do not use the device with MRI / X-ray room /AED equipment together Do not use on infant. 4 Do not immerse the machine in liquids or expose the machine to extremely high humidity. QOCA pulse oximeter measurement will be influenced by environment, usage errors or patient conditions. It is recommended to use the index finger, middle finger and ring finger for measurementFor long-term use, please change the use position every 4 hours, and check the patient's status regularly. Please avoid injury, disability, or other medical conditions that may cause abnormal test results Keep still and stable during the measurement. Do not move or shake your body, so as not to affect the measurement The following conditions will affect the accuracy of interpretation of result. Examplescontrast medianail polish artificial nails anemia weak pulse signal circulatory 5 embarrassment carboxyhemoglobin oxyhemoglobin abnormal environment lightlow perfusion.etc. Please make sure that the indicator lights of the machine can be clearly identified in the operating environment The measurement information cannot be provided in an error action. The device will automatically stop the measuring process when battery is out of energy. Please use the compatible model of charging cable and adaptor for battery charging. When the QOCA pulse oximeter is working, please avoid using any instruments or equipment that will affect measurement accuracy (eg, the sphygmomanometer will affect blood flow and cause incorrect measurement values). When QOCA pulse oximeter is working, please avoid using other electronic equipment nearby; if it must be used with other 6 electronic equipment at the same time, please confirm that the device still maintains the normal measuring operation. Do not replace or connect other batteries in device. This may cause the QOCA pulse oximeter to burst Please avoid the environment of electromagnetic interference during measuring and avoid products that can cause electromagnetic interference (eg, electric blankets). Please be careful of the device impact or fall Do not clean the device with corrosive or abrasive cleaning agents. Pay attention to ensure that the device is not swallowed by pets or children. Do not expose deivce to extreme temperatures, extremely moist environments, dust, or direct sunlight. 7 If SpO2 value is lower than 95% during the measuring, please contact a doctor for confirmation. Please use this product probe correctly to avoid injuring the fingers. A function tester cannot be used to assess the accuracy of a pulse oximeter device. Please check with doctor if you have any question about the measured SpO2 and pulse rate value data. 8 PRODUCT OVERVIEW Indication for Use QOCA pulse oximeter (wireless) is a fingertip and portable device intended for measuring functional oxygen saturation (SpO2) and pulse rate for adults. QOCA pulse oximeter device is a non-invasive measurement for continuous and spot check in homecare and professional caring environment. It is designed for during no-motion condition. The device should be worn on the index finger, middle finger or ring finger. 9 PACKAGE CONTENT QOCA pulse oximeter product package:

List QOCA pulse oximeter (Model: o2a) Adaptor (Model: WB-10Q05FU) User manual Lanyard QOCA power bank* (Model: o2a-c1) QOCA power bank Type C cable*

QOCA SpO2 app*

* Indicates as an optional product 10 1pcs 1pcs 1pcs 1pcs Product components QOCA pulse oximeter (Model: o2a) Power key button LCD display LED indicator Type C Finger input 11 Adaptor 12 LCD display Battery BLE status SpO2 PRbpm Signal index 13 Product requirement The following items are required before using QOCA pulse oximeter Smart phone with Bluetooth function*

(Android version 9 or above; A display resolution of 1920x1080 or above) QOCA SpO2 APP*

Notice:

Items not included in the product package QOCA pulse oximeter could be operated without QOCA SpO2 APP 14 PREPARATION Please follow up item steps :

1. Charging pulse oximeter battery first 2. QOCA SpO2 APP installation on smartphone 3. Enable bluetooth function Pulse oximeter charging notes Please use adaptor for device battery charging. The LED indicator will run orange color flashing. The LED indicator will run green color with full battery. QOCA SpO2 APP :

Please turn on the bluetooth function of smart phone. 15 Measurement Start Step1 Press power key button and turn on the deviceThe display will turn on when the device is ready. It will automatically shut down after 10 seconds without finger detecting. Step2 Put your finger into device rubber. Do not move during measurement. Step3 The measurement result will be displayed on the screen. According to the detected singal strength, the measured data will change accordingly. When the measurement of SpO2 and PR is lower than warning setting, the LCD display will show highlight screen and trigger vibrator function until the condition is removed. 16 Step4 The pulse oximeter will automatically shut down after removing your finger for more than 10 seconds. QOCA pulse oximeter LCD display Screen after boot 17 Measuring screen SpO2 Lo Lower than SpO2 measurable value PR Hi PR Lo Higher than PR measurable value Lower than PR measurable value SpO2 Highlight Over the warning value setting PR Highlight Over the warning value setting Er

Error measuring data No signal detection Vibration Function trigger when over warning value setting 18 QOCA SpO2 APP Bonding mode:

Step1 Open the application details page and click "Pair pulse oximeter"

Step2 Turn on the pulse oximeter first, then press and hold the power button for 3 seconds to enter pairing mode. Step3 On the Connectable pulse oximeter page of the app, click the serial number to pair, and confirm the pairing process after the apps instructions appearing. 19 QOCA SpO2 APP main page:

Information Bonding status SpO2 Battery level PRbpm SI PPG wave 20 Main page description:

Information Setting Bonding status Paired pulse oximeter serial number Battery level Show battery level SpO2 (Functional Show range 70-100%

oxygen saturation) PR (Pulse rate) Show range 30-240 bpm SI (Signal index) Show measuring singal strenth PPG wave Show PPG wave 21 Information:

Device information Pair and Repair device Serial number Paired serial number Cancel paired serial number Battery level Show battery level Screen lightness Adjust device screen lightness Low/Midium/High SpO2 warning setting Warning range 80-94%

High PR warning setting Warning range 100-200 bpm Low PR warning setting Warning range 30-90 bpm Measurement interval Continous/1 minute/3 minutes/5 minutes Device version Device software version App version App software version 22 Notice: The device will enter power saving mode when measurement interval setting change to 1 minute/3 minutes/5 minutes Data transmittion 1. The mobile phone needs to install the QOCA SpO2 app and activate bluetooth connectionThe measurement results on pulse oximeter will be transmitted to mobile phone via Bluetooth transmission. Ateention: please make sure the connection between device and phone. The device must be connected with phone at bonding mode. (The outdoor wireless transmission distance is within 10 meters) 23 Indicator Event Pulse Action Light Indicator Press and hold the Flashing green light oximeter power button for 1 until power on is power on second completed Pulse Automatic power off No finger is detected oximeter power off for more than 10 seconds Pulse none Flashing orange light oximeter low battery Pulse Adaptor or power Flashing orange light oximeter bank plug in charging 24 pulse Adaptor or power Steady green light oximeter full bank plug in battery Bonding mode Press and hold the Flashing blue light power button for 3 seconds after booting 25 INFORMATION Clean and Preservation Clean Turn off the device before cleaning. Clean the device and finger rubber with a water dampened cloth or neutral detergent in moderation. You could also use alcohol to clean. Please clean the device after use. Do not immerse the device in any liquid or water for cleaning. Preservation Do not place in direct sunlight or places with high temperature and humidity. The suitable storage environment is -20 degrees Celsius to 60 degrees Celsius, and the relative humidity is 10%

to 95%. Do not drop the device and avoid collision. To avoid damage, do not disassemble the device. No need for device regular calibration 26 Techinical data Model o2a pulse oximeter Pulse rate range30~240 bpm Pulse rate accuracy3 or 3 %

Functional Oxygen Saturation Range :

70~100%

Functional Oxygen Saturation Accuracy :

3 %

Sampling Rate (Hz)100Hz Value refresh period : 1/ every second Optical sensor Red light (wavelength is 660nm), Infrared

(wavelength is 905nm); Typical mV : 7mV 27 Connectivity Bluetooth transmit distance10 meters

(Open space) Battery Lithium battery; 3.8V/298 mAh Battery life Pulse oximeter continous measuring 12 hours (BLE off) Input 5V/0.16A Working 5 40, 10% 95% (non-condensing) Temperature /

Humidity Storage

-20 60, 10% 95% (non-condensing) Temperature /

Humidity Atmospheric 800 hPa to 1013 hPa Pressure Range 28 Altitude 2,000 m IP Rating IP22 Weight 30 5g (Adaptor not included) Dimension (mm) 60.8 x 26.8 x 24.5 0.5mm Standard IEC/EN60601-1; IEC/EN60601-1-2 IEC/EN60601-1-11; ISO80601-2-61 Function tester Fluke biomedical model : INDEX2LFE 29 For additional technical information, contact Quanta Customer Support Department. Quanta Computer Inc. (QCI) Address:

No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City 333, Taiwan TEL: +886-3-327-2345 FAX: +886-3-318-4207 Email: MedicalService@quantatw.com Warranty This instrument is covered by a 1 year guarantee from the date of purchase, batteries and accessories are not included. The guarantee does not cover damage, accidents or non-compliance with the instruction manual. 30 Trouble shouting Problem Possible cause Solution pulse oximeter Low power Please charge battery cant power on BLE or Bonding Check phone Enable bluetooth connectivity fail bluetooth setting function Device didnt power Please make sure the on device is at power on status SpO2 and PR No finger input Put your finger back in data cannot be detected place displayed Device bluetooth Please check whether connection off the connection and pairing are working, then power on again 31 SpO2 and PR Trembling fingers or Keep fingers and body cannot be body movement steady displayed stably Improper finger Put your finger back in placement place No LCD display When no signal is Please power on the information detected, it will device and then put automatically power your finger back in off place Low battery Please charge battery Enter power saving Normal case. Press the mode power key button and the screen will light up briefly electromagnetic Please stay away from interference the environment 32 Abnormal Lower finger surface Please raise your measurement temperature finger temperature results Foreign Influence Please remove foreign on finger surface objects Hi/Lo/Er on screen Put your finger back in place SpO2 and PR data The set warning range are highlighted and is activated. vibration trigger Please exclude the situation If the problems cannot be resolved, please contact the supplier or hospital for further information, and do not disassemble the device. 33 Federal Communications Commission (FCC) Statement The FCC ID is HFSMH7 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the users authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1) This device may not cause interference and 2) This device must accept any interference, including interference that may cause undesired operation of the device. 15.105(b) 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. 34 This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC RF Radiation Exposure Statement:

1) This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. 35 For body worn operation, this device has been tested and meets FCC RF exposure guidelines. When used with an accessory that contains metal may not ensure compliance with FCC RF exposure guidelines Regulatory Marks The QOCA PORTABLE ECG MONITORING DEVICE conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency, enhance transmitting power or alter original characteristic as well as performance to an approved low power radio-frequency devices. Article 14 The low power radio-frequency devices shall not influence aircraft security and interfere with legal communications. If found, the user shall cease operation immediately until no interference is achieved. 36 The said legal communications means radio communications is operated in compliance with the Telecommunications Act. The low power radio-frequency devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. 37 Signs and Symbols Type BF applied part Caution Separate collection for electrical and electronic equipment (WEEE) Follow instructions for use IP22 Protected against solid foreign objects of 12.5 mm diameter and greater and protection against vertically falling water drops when enclosure is tilted at 15 degrees FCC ID Identifies unit has been registered as a radio device No SpO2 Alarms 38 Barcode_ver.2A 39

30.6mm QOCA pulse oximeter Model: 02 Applicable input power modo!

wa-s0a0sru Input'5V /0.168 FOC ID: HFSMH7 P22) A

(01)047 13696848479

(21)MH7xKYYWWSss

FCC, Request for non-disclosure Date: 16-Jul-10 RF_501, Issue 6 Page 1 of 1 Company Name: Quanta Computer Inc. Address: No. 188, Wenhua 2nd Road, Guishan District, Taoyuan City 33377, Taiwan City: Taoyuan City Country: Taiwan To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: HESMH7 Reference number: #444#+

Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application:

L] Bill(s) of Material XX] Block Diagrams J Operational Description [X] Schematic Diagrams [_] Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission's policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (note 1):

[XX] Internal Photos [X] Users Manual XX] Test Set-up Photos XX] External Photos Planned Release Date STC: 180 days (notes 2, 3, 4, 5) Date: 2022/05/25 Name and signature of applicant: Joyce Kuo Soy : bs Notes:

1) A document or type of document can only have ONE type of confidentiality!

2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)!

3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this!

5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period

RF_ 160, Issue 04 Quanta Computer Inc No. 188, Wenhua 2nd Road, Guishan District, Taoyuan City 33377, Taiwan Tel: +886-3-3272345 Fax: +886-3-3961334 Declaration of Authorization We Name: Quanta Computer Inc. Address: No. 188, Wenhua 2nd Road, Guishan District, Taoyuan City 33377, Taiwan City: Taoyuan City Country: Taiwan Declare that:

Name Representative of agent: Jim Chang ) Agent Company name: SGS Taiwan Ltd. Address: 134, Wu Kung Road, Wu ku Industrial Zone TW- New Taipei City 24803 City: New Taipei City Country: Taiwan is authorized to apply for Certification of the following product(s):

Product description: QOCA pulse oximeter Type designation: o2a Trademark: Quanta, QOCA Validity/ expiry date: Dec 31, 2023 on our behalf, including signing of all documents relating to these matters. Date: 2022/5/25 City: Taoyuan City Name: Joyce Kuo Function: Coordinator memretts| yor. tee Notes:

(1): Required for FCC application

(2): For FCC it must be the Grantee Code owner or the authonzed agent.