Pulse oximeter, fingertip, rechargeable

GENERAL DESCRIPTION
Finger clip mounted, rechargeable battery-powered, all-in-one pulse oximeter displaying patient oxygen saturation (SpO2) and pulse rate. Intended for spot-checking of adult and paediatric patients.

TECHNICAL SPECIFICATIONS
Measurement:
SpO2 and pulse rate monitor for adults and children.
Specified for finger diameters from 8mm to 25mm.
SpO2 detection includes the range: 70 - 100 %.  Also capable of measuring a wider range of saturation.
SpO2 resolution: 1 %.
SpO2 accuracy in the range 70 - 99%: ± 2 % under normal conditions.
   
Pulse Rate detection includes the range 18 - 250 bpm.
Pulse Rate resolution: 1 bpm.
Pulse Rate accuracy ± 3 bpm.

Display:
Multidirectional OLED display of SpO2, pulse rate (PR), perfusion index (PI), plethysmogram and battery indicator.
Can switch between 6 different display interfaces.

Features:
Design enables use in demanding environments, e.g. shock and vibration as per ISO 80601-2-61.
Enclosure protection IP22.
Suitable for cleaning and disinfection.

Electrical characteristics:
Operated by internal rechargeable battery.
Charger to have protection against over-voltage and over-current line conditions and be certified to IEC 60601-1.
Batteries allow approximately 16 hours of operation after full recharge or at least 2500 spot checks.
Automatic power-off.

ENVIRONMENTAL CONDITIONS
Operating conditions: 5 to 40°C, 30-80% RH
Storage conditions: -20 to 60°C, 10-95% RH
 
SUPPLIED WITH
1 x built-in rechargeable battery.
1 x USB cable for charging battery.
1 x carry/storage case.
1 x set user and maintenance manuals in English/French/Spanish at minimum. Other languages can be requested. If digital manuals will be provided, then a quick reference guide in English/French/Spanish languages which clearly indicates the URL to access complete manuals will be supplied with each device.
1 x certificate of calibration and inspection.
1 x list of all equipment and procedures required for routine maintenance.
1 x document with contact details of manufacturer, supplier and local service agent.
 
WARRANTY
Includes 2-year standard warranty, dated from the completion of the terms of delivery.
 
ESTIMATED LIFE SPAN
5 years.

WEIGHT & VOLUME (Packaged)
Weight: 0.07kg
Volume: 0.3dm³

ESTIMATED LEAD TIME
4 - 6 weeks

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
Li-Ion (Lithium-Ion) battery, UN 3480 – 3481 Class 9, Packing Group II
 
MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDD 93/42/EEC or MDR 2017/745/EEC as Class IIa device.
USA FDA 510(k) (Class II).

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified to ISO 13485 Medical devices -- Quality management systems - Requirements for regulatory purposes.

SAFETY AND PRODUCT STANDARDS
Complies with the following standards:
ISO 14971 Medical Devices -- Application of risk management to medical devices.
ISO 80601-2-61 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
IEC 60601-1 Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic compatibility -- Requirements and tests.