Pulse oximeter,handheld,cont,w/resp rate

GENERAL DESCRIPTION
Handheld, portable, rechargeable battery powered pulse oximeter, for the noninvasive spot-checking or continuous monitoring of patient oxygen saturation (SpO2), pulse rate and respiratory rate.

TECHNICAL SPECIFICATIONS
Measurement:
SpO2 and pulse rate monitor, with plethysmography waveform, for infants, children and 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, adults).

Pulse Rate detection 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 range: 4 to 70 rpm
Respiratory rate resolution: 1 rpm
Respiratory rate accuracy (no motion, adults/paediatrics (> 2 years)): within ± 3 rpm A(RMS), ± 1 rpm mean error
(Note: device is indicated for spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients (> 2 years) during no motion conditions).

Display:
Data display refresh rate: every 1 s
Display with main parameters: %SpO2, pulse rate, respiratory rate, signal quality, status messages, battery state indication.

Features:
Suitable for detection in low perfusion conditions.
Design enables use in demanding environments, e.g. shock, vibration.
Automatic correction for movement and ambient light artefacts.
Audible and visual alarms for low saturation and high/low pulse rate, thresholds settable by user.
Audible and visual alarms for sensor error or disconnected, system errors, low battery.
Alarm override and temporary silencing function.
Capable of working with, and supplied with, adult, paediatric and neonatal reusable probes.

Casing:
Enclosure protection IP22.
Case and reusable 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 operating by mains power and by battery.
Automatic switch between battery and mains powered modes.
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).

SUPPLIED WITH
2 x universal reusable sensors (for adults or children ≥ 3kg)
1 x battery charger
1 x set user and maintenance manuals in English/French/Spanish language. Other languages can be requested.
Contact details of manufacturer provided in Operator Manual.

ENVIRONMENTAL CONDITIONS
Operating conditions: 0 to 40C, 10 to 95 % relative humidity non-condensing.
Storage conditions (packaged): -20 to 60C, 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: 1.0 kg
Volume: 4.4 dm³

WARRANTY
24 months

COMPONENTS OF A KIT
No

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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