Monitor,resp.rate,automated,rechargeable

GENERAL DESCRIPTION
Handheld, portable, battery powered device displaying respiratory ratefor children and neonates. Is equipped with a rechargeable battery.

TECHNICAL SPECIFICATIONS
MEASUREMENT
Respiratory rate monitor, for children and full-term neonates.
Respiratory rate includes the range 10 to 90 rpm.
Respiratory rate resolution: 1 rpm
Respiratory rate accuracy within ± 2 rpm in ideal conditions.
Indicates when measurement is completed.

DISPLAY
Display with main parameters: respiratory rate, measurement completed, battery state indication.
Patient age group input feature.
Display indicates high and normal respiratory rate count for inputted age.

FEATURES
Design enables use in demanding environments.
Automatic correction for movement and alert to user if movement impacts reading.
Audible and/or visual alarms for system errors, low battery.
Enclosure protection IPX2 or better.
Outer case and patient mounting is suitable for cleaning and disinfection with hospital-grade cleaning products.
Overall device weight < 100 g.

ELECTRICAL CHARACTERISTICS
Operated by rechargeable battery power supply.
2 fixed x rechargeable AAA (Nickel/Metal hydride, alkaline electrolyte Battery), supplied within equipment
Battery lifetime ≥200 measurements with every charge.
Automatic power-off after period of no use.

SUPPLIED WITH
1 x strap to secure the device on the chest of the newborn
1 x battery charger, plug style and voltage as requested for local supply
1 x USB charging cable
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 document with contact details of manufacturer.

ENVIRONMENTAL CONDITIONS
Operation conditions: 5 to 40 deg C, 10 to 90 % relative humidity non-condensing
Storage conditions (Packaged): -20 to 50 deg C, 10 to 95% relative humidity non-condensing

WARRANTY
12 Months

WEIGHT/VOLUME
Weight: 0.345 kg
Volume: 1.6 dm3

COMPONENT OF A KIT
No

RELATED PRODUCTS
S0845011 Timer,for respiration,ARI (mark 2)
S0002031 Monitor,patient,portable,w/access

ALTERNATIVE PRODUCTS
S0686502 Monitor,resp.rate,automated,non-recharg

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
Must comply with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes