Monitor,resp.rate,automated,non-recharg

GENERAL DESCRIPTION
Handheld, portable, battery powered device displaying respiratory rate for children and neonates. Is equipped with a non-rechargeable, non-replaceable 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 single use, 2 x AAA non-replaceable, Alkaline Zinc-Manganese Dry Batteries power supply.
Battery lifetime ≥2000 measurements.
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 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
Operarting 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

ESTIMATED LEAD TIME
12 weeks

STORAGE INSTRUCTIONS: -20 °C to 50 °C; 10% to 95% RH

MATERIAL SAFETY DATA SHEET INFORMATION (MSDS): (available)
2 x Fixed alkaline batteries
The common known rules for handling of chemical power source should be obeyed. Do not heat, recharge, disassemble the product or dispose of infire.

WEIGHT/VOLUME
Weight: 0.2 kg (packaged)
Volume: 0.6 dm3 (packaged)

WARRANTY
12 months

COMPONENTS OF A KIT
No

ALTERNATIVE PRODUCTS
S0686501 Monitor,resp.rate,automated,rechargeable

RELATED PRODUCTS
S0845011 Timer,for respiration,ARI (mark 2)
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
Must comply with the following standards:
ISO 13485:2003 Medical devices -Quality management systems -- Requirements for regulatory purposes