Product Overview
Rapid, non‑invasive temporal artery thermometer for quick fever screening in clinics and emergencies, delivering accurate readings in seconds.OK
Device Specifications and Features
• Compact, lightweight design (weight 120 g, dimensions 140 × 70 × 30 mm). • Dual‑sensor architecture: infrared emitter and photodiode for high‑resolution temporal artery temperature. • Rapid‑scan mode delivers a reading in 2 seconds; standard mode in 5 seconds. • Accuracy ±0.3 °C (range –10 °C to 45 °C). • Built‑in 2‑year battery with 2000 read cycles; USB‑C charging (5 V/2 A). • Bluetooth 5.0 connectivity for real‑time data sync to mobile app. • Compliance with IEC 60601‑1, CE, and FDA 510(k) clearance. • Ergonomic handle with anti‑glare display. • Software supports multilingual UI and audit trail logging. • Supports dual‑mode operation for clinical and home use. • Export data via USB. • USB. • Probe‑ .
Safety and Compliance
The SmartGlow Exergen scanner meets IEC 60601‑1, CE, and FDA 510(k) standards, ensuring safe, reliable use in clinical and home settings for users.!!
Compliance with Medical Device Regulations
The SmartGlow Exergen temporal scanner complies with IEC 60601‑1 for electrical safety, ISO 13485 for quality management, and CE marking under the Medical Device Regulation (MDR) 2017/745. It also received FDA 510(k) clearance, demonstrating equivalence to predicate devices and meeting performance, safety, and labeling requirements. The device undergoes rigorous risk analysis, post‑market surveillance, and software validation per IEC 62304. All documentation, including clinical evaluation reports and risk management files, is maintained in accordance with regulatory guidelines to ensure ongoing compliance and patient safety. All safety protocols are per now IEC 60601-1 and ISO 14971;
Unpacking and Components
The package contains the scanner, power adapter, USB cable, quick‑start guide, and a 12‑month warranty card, all neatly boxed for easy transport. Ready
List of Included Accessories
• SmartGlow Exergen Temporal Scanner unit
• 5 V/2 A power adapter with detachable USB-C cable
• Quick‑start guide (PDF & printed copy)
• 12‑month limited warranty card
• Replacement ear‑probe tip (single‑use disposable)
• Cleaning wipes (isopropyl‑based) for probe surface
• Anti‑glare screen protector for display
• Carrying pouch with reflective strip for easy identification
• Instructional video link (QR code included)
• Optional battery pack (12 V, 2000 mAh) for field use
• 3‑day battery pack (12 V, 2000 mAh) for extended use
• USB‑C to micro‑USB adapter for older devices
• Quick‑connect cable (1 m) for rapid deployment
• Instruction manual (English, Spanish, French)
Installation and Setup
Connect power, place scanner on forehead, calibrate, then scan. Follow onscreen prompts for first‑time setup. Device ready in minutes.(USB‑C)✓!.
Initial Power‑On Procedure
Step 1: Connect the scanner to a 5V USB‑C source or charge it; Step 2: Press the power button; a blue LED lights and the device boots. Step 3: Wait for the startup splash; a tone confirms readiness. Step 4: If the LED stays green for 5 s, the scanner is ready. If it flashes amber, verify the cable and retry. Step 5: For first‑time use, complete the quick calibration: enter patient ID, select language, and confirm location. Once calibrated, the main menu appears and the scanner is ready for measurements. For battery operation, replace the CR‑2450 cell when the amber light turns. Store the unit in a cool, dry place when not in use. The device automatically logs each measurement to the internal memory for audit trails.
Calibration Procedure
select Calibrate, apply sensor to forehead, press Start, wait 5 s for zero,confirm with beep,then device is ready.
Step‑by‑Step Calibration Guide
Power on the device and allow initialization. 2. Clean the sensor probe. 3. Connect to PC via USB and launch the calibration utility. 4. Select “Temperature Reference” and immerse probe in a 37.0 °C water bath. 5. Verify bath temperature with a calibrated thermometer. 6. Click “Start Calibration” and wait for the reference to be recorded. 7. If the recorded value differs by more than ±0.2 °C, repeat steps 4‑6. 8. Save the calibration data, disconnect USB, and reboot the scanner. The device is now calibrated for accurate fever screening. Follow these steps to ensure reliable temperature measurements during patient screening. Regular calibration checks are recommended every 6 months.
Operating Instructions
Place probe on forehead, press scan, wait 3 s, read display. Repeat if needed. Follow safety guidelines. Ensure probe is clean before use. Dry.
Scanning Protocols and Settings
Power on the device. 2. Place the probe on the patient’s forehead over the temporal artery. 3. Press the scan button; the device auto‑detects contact and measures in 3 s. 4. Read the temperature and confidence indicator. 5. If confidence is low, wipe the probe tip and repeat. 6. For rapid screening, hold the button for 5 s to get continuous readings. 7. Log results to internal memory or export via USB. 8. Adjust display brightness and language in settings. 9. Follow safety guidelines when handling the probe. 10. Ensure the probe tip is clean before each use to maintain accuracy. 11. Store the device in a cool, dry place when not in use. 12. Replace the probe tip annually to ensure sterility. 13. Charge.
Maintenance and Cleaning
Clean probe tip with 70% isopropyl alcohol after each use. Dry with lint‑free cloth. Store in case. Replace tip yearly. Avoid water. Dry. for accuracy.
Recommended Cleaning Schedule
Recommended cleaning schedule: After each use, wipe the probe tip with a 70% isopropyl alcohol pad, ensuring no residue remains. Allow the tip to air‑dry for at least 30 seconds before re‑engaging. Weekly, perform a deeper clean by soaking a disposable tip in a mild antiseptic solution for 5 minutes, then rinse with sterile water and dry thoroughly. Monthly, inspect the probe for signs of wear or damage; replace the tip if it shows cracks, discoloration, or loss of sensitivity. Store the device in a clean, dry case when not in use. Follow these steps to maintain accuracy, hygiene, and prolong device life. Daily checks help maintain device integrity; replace the probe tip annually if any wear or contamination is detected to ensure reliable readings!!!
Problem Diagnosis and Troubleshooting
Check battery, reset, clean probe, update firmware. If errors persist, contact support with serial number and error code. Check firmware updates Now
Common Issues and Fixes
No power display – Verify the battery is fully inserted and charged; replace with a fresh lithium‑ion pack if voltage is below 3.2 V. Reset the unit by holding the power button for five seconds, then power on again. 2. Inaccurate temperature readings – Clean the infrared sensor window with a lint‑free cloth and isopropyl alcohol; ensure the probe is perpendicular to the forehead and the patient’s skin is dry. Calibrate the device using self‑test before each shift. 3. Error code E‑01 – Probe communication fault. Disconnect, reseat cable, inspect pins, then restart scanner. 4. Bluetooth pairing failure – Delete old entries, enable pairing, keep scanner within 1 m of tablet. Update firmware if needed. Fix now.!
Warranty and Support
Two-year limited warranty covers defects; call 1-800-555-1234 or email support@exergen.com for repairs online help.
Warranty Terms and Service Contact
The SmartGlow Exergen Temporal Scanner is covered by a two‑year limited warranty from purchase date. It protects against manufacturing defects under normal use. Damage from misuse, drops, liquids, or unauthorized repairs is excluded. For warranty claims, contact support within 30 days of defect notice. Call 1‑800‑555‑1234, email support@exergen.com, or use the online claim form at www.exergen.com/support. Provide proof of purchase, serial number, and issue description. Our service center will evaluate the unit and, if warranted, repair or replace it at no cost. Warranty does not cover batteries, which are non‑replaceable. Warranty is non‑transferable and valid only in the country of purchase. For info, refer to the full warranty booklet on our website
Regulatory Information
CE marked for EU, FDA cleared Class I, ISO 13485 compliant. Use per instructions. Warranty valid 2 years. For support, call 1‑800‑555‑1234 for inquiries.??
CE Marking and FDA Clearance
The SmartGlow Exergen Temporal Scanner complies with European Union medical device directives, carrying the CE mark that confirms conformity with essential safety and performance requirements. In the United States, the device has received FDA clearance as a Class I medical device, indicating that it meets the necessary regulatory standards for safe use in clinical and point‑of‑care settings. The CE marking process involved rigorous conformity assessment, risk management, and quality system audits in accordance with ISO 14971 and ISO 13485. FDA clearance required submission of a 510(k) pre‑market notification, demonstrating substantial equivalence to a legally marketed predicate device. Worldwide approval, valid!.
Safety Warnings and Precautions
Do not expose sensor to liquids.Keepdevice dry, avoid contact with skin lesions. Use only with calibrated power. Follow manufacturer instructions
Do Not Use With
The SmartGlow Exergen Temporal Scanner must not be used with reflective or metallic accessories that can interfere with its optical sensor. Avoid applying it to skin with burns, open wounds, or severe dermatitis. Do not use the device when it is wet, exposed to liquids, or in environments with high ambient noise or vibration, as these can compromise accuracy. The scanner is not intended for use with external power supplies other than the supplied charger, nor should it be combined with other medical devices emitting electromagnetic interference. Always follow the manufacturer’s safety instructions and seek professional advice before using the scanner in non‑standard settings. The device should not be used on children with a fever above 41°C (105.8°F) or on individuals wearing contact lenses that could reflect light. Do not expose the sensor to direct sunlight or intense infrared sources. The scanner is not compatible with any external batteries or adapters, and it should not be used during electrical storms or in areas with known electromagnetic disturbances.
FAQs
Q: How long does a scan take? A: 2–3 seconds. Q: Battery life? A: 30 uses per charge. Q: Calibration? A: Auto‑calibrates on power‑on. in 5 minutes. Now
Frequently Asked Questions
Q1: How long does a scan take? A1: 2–3 seconds. Q2: Battery life? A2: 30 uses per charge, lasting up to 8 hours. Q3: Calibration? A3: Device auto‑calibrates on power‑on, no manual steps needed. Q4: Can it be used on infants? A4: Yes, with pediatric mode. Q5: How to clean? A5: Wipe with alcohol‑free wipes; avoid liquids. Q6: Warranty? A6: 12‑month limited warranty, support via email or phone. Q7: Is it CE and FDA approved? A7: Yes, CE marked and cleared by FDA for fever screening. Q8: What if the device shows error? A8: Reset by holding power button for 5 seconds; if persists, contact support. Q9: How many scans per battery? A9: Approximately 30 scans. Q10: Can it be used in high humidity? A10: Yes, with caution. Q11: Device reusable? A11: Yes.
Software/Firmware Updates
Download v1.2 from Exergen, connect via USB, update (≈2 min). Improves accuracy, battery life, logs changes.OK
Update Process and Version Log
Connect the SmartGlow scanner to a PC with the supplied USB‑C cable, launch the Exergen Update Utility (Windows 10+), and let it detect the device. If a newer firmware is found, click Download (≈4 MB) and then Install. The unit reboots, applies the update in about 90 seconds, and displays the new version number on the screen. Updates are stored in the device log for reference now.
- v1.0 – 01/15/2023: Initial release.
- v1.1 – 06/02/2023: Bluetooth‑LE added.
- v1.2 – 11/18/2023: Low‑ambient accuracy boost.
- v1.3 – 04/10/2024: Security patch.
- v1.4 – 09/25/2024: CSV log export.
Glossary of Terms
Temp. Scan: IR reading. Firmware: software. Calibration: sensor alignment. BLE: Bluetooth LE. Log: v1.4 data record.
Key Terminology Explained
Temp. Scan: Infrared measurement of temporal artery surface temperature, yielding core body temperature within 2 °C accuracy. Firmware: Embedded software controlling sensor, data processing, and communication. Calibration: Process aligning sensor output to reference standards, performed monthly. BLE: Bluetooth Low Energy, enabling wireless data transfer to mobile apps. Log: Internal memory storing last 100 readings with timestamps. Battery: Rechargeable Li‑Ion, 3 Ah, supports 30 days continuous use. Sensor: IR probe; Probe: contact tip; Data: numeric value; Display: LCD; Connectivity: BLE; Firmware Update: OTA; Calibration Mode: auto; Battery Life: 30 days; Warranty: 2 years; Safety: non‑contact; Accuracy: ±0.5°C. All terms defined. clear!