Pulse oximeter,handheld, incl.resp. rate

GENERAL DESCRIPTION
Handheld, portable, rechargeable battery powered pulse oximeter, displaying patient oxygen saturation (SpO2), pulse rate and respiratory rate in real time.

TECHNICAL SPECIFICATIONS
Measurement:
SpO2, pulse rate and respiratory rate monitor, for infants, children, adults.
SpO2 detection includes the range: 70 - 100 %.
SpO2 resolution: 1 %.
SpO2 accuracy (in the range at least 70 - 100%): ± 2% (no motion, low perfusion), ± 3% (motion) for all patients (infants, children and adults).
Pulse Rate detection includes the range: 25 - 240 bpm.
Pulse Rate resolution: 1 bpm.
Pulse Rate accuracy: within ± 3 bpm (no motion, low perfusion), ± 5 bpm (motion) for all patients (infants, children, adults).
Respiratory rate includes the range: 4 to 90 rpm.
Respiratory rate resolution: 1 rpm
Respiratory rate accuracy within ± 1 rpm in ideal conditions

Display:
Data display refresh rate ≤ 1 s
Display with main parameters: %SpO2, pulse rate, respiratory rate, signal quality, status messages, battery state indication.
Patient age group input feature.
Display indicates high and normal respiratory rate count for inputted age.
Display indicates when SpO2 < 90% (hypoxaemia per WHO guidelines.)

Features:
Suitable for detection in low perfusion conditions down to perfusion index of 0.1%.
Design enables use in demanding environments, e.g. shock, vibration
Automatic correction for movement and ambient light artefacts
Audible and visual alarms for sensor error or disconnected, system errors, low battery.

Casing:
Enclosure protection IPX2.
Case and probe suitable for cleaning and disinfection with hospital-grade cleaning products.
Overall device and probe weight < 300 g.

Electrical characteristics:
Operated by rechargeable, non-replaceable Li-ion battery, power supply
External AC battery charger, plug style and voltage as per local supply.
Charger certified to IEC 60601-1.
Protection against defibrillator discharges.
Suitable for operation by battery and by mains power supply, if connected and/or recharging.
Automatic switch between battery and mains powered modes, when recharging or in mains power failure.
The display shows which power source is in use.
Running time on battery only ≥ 12 hours (24h at lowest screen brightness and beep tone turned off).
Automatic power-off after period of no use.

SUPPLIED WITH
2 x universal reusable sensors (for adults or children ≥ 3kg)
1 x battery charger
1 x set user and maintenance manuals, hard and soft copies, in local language, or in agreed other language if local is not available.
1 x list of equipment and procedures required for local calibration and routine maintenance.
1 x list of all spares and accessories, with part numbers and contact details for parts supply.
1 x document with contact details of manufacturer, supplier and local service agent.

ENVIRONMENTAL CONDITIONS
Operarting conditions: 5 to 40C, 10 to 90 % relative humidity non-condensing
Storage conditions (packaged): 0 to 50C, 10 to 95% relative humidity non-condensing

ESTIMATED LEAD TIME
2-4 weeks to FCA port/airport in USA

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS)
Li-Ion (Lithium-Ion) battery, UN 3480 – 3481 Class 9, Packing Group II

WEIGHT/VOLUME
Weight: 0.8 kg (packaged)
Volume: 5.1 dm3 (packaged)

WARRANTY
24 months

LIFE SPAN
7-10 years (Varies considerably depending on field usage and storage conditions)

COMPONENTS OF A KIT
No

RELATED PRODUCTS
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S0845212 Pulse oximeter,handheld,cont,w/resp rate
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S0002031 Monitor,patient,portable,w/access

REGULATION & CONFORMITY REQUIREMENTS
CE mark conforming to Medical Device Directive 93/42/EEC
CE Certificate (class IIa or higher)

CLASSIFICATION
93/42/EEC Risk class IIa or higher– CE certificate

SAFETY & PRODUCT STANDARDS
Complies with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes
ISO 80601-2-61 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
Charger certified to IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance