Co Analyzher

Co Check Pro
Product
ISO 9001:2008 ISO 13485:2003

A simple approach to
CARBON MONOXIDE
breath screening
Live environmental CO capture
Audio-visual indicators

PRODUCT OVERVIEW

Serenity CO Analyzer PRO has been designed to enable all healthcare professionals to carry out quick and
simple breath tests that provide comprehensive results. A single breath from a person will instantly
display results in PPM and %COHb. Both results are backed up with an appropriate colour light
to show a non-smoker, light smoker, smoker and heavy smoker.
The device is capable of giving a real time display of Environmental CO levels prior to carrying out
a breath test. When activated the Enviromental mode is a live measurement, when moving
from room to room measurements will fluctuate depending on what Carbon Monoxide levels
are present at the time. Environmental results are instantly displayed in PPM.

Distributed by:
PT. SERENITY INDONESIA
Komplek Ruko Permata Kota Blok Q No 10
Jl. Pangeran Tubagus Angke No. 170
Jakarta 14450, Indonesia
E info@serenityindonesia.com
W www.serenityindonesia.com
KEMENKES RI AKL: 20401412418
SERENITY CO Analyzer PRO
TECHNICAL DATA
Product : Serenity CO Analyzer PRO

Gas Detected : Carbon Monoxide

Display : 128 x 64 pixel Graphic LCD

Result : PPM and %COHB

Concentration Range : 0 - 99PPM

Detection Sensor Used : Electrochemical fuel cell

Sensitivity : 1ppm

Accuracy (repeatability) : ±2%

Operation temperature range : 5 - 35 °C

Operating Pressure : Atmospheric +/- 10%

Operating Humidity : 30% to 90% RH

Operating Altitude : Sea Level to 6000 ft

Storage Temperature : -20 tp +70°C

Storage Humidity : 10% to 90% RH

Hydrogen cross-sensitivity :<10% ; < 12% at 20°C

Sensor operating life : 2-5 years, 2 years warranty

Sensor Drift : <2% per month

Power Supply : Single 9V Pp3 battery

Size : 135mm x 60mm x 60mm

Weight (approximate) : 160g including battery

Live envir onm
e
Indicator Levels : Green 0 - 6PPM Audio-visual ntal CO captuer
Yellow 7 - 10PPM indicators
Red 11 - 20PPM.
Flashing red and audible alarm 20+ PPM.

Language display : Indonesian

Medical Safety Standard : Medical Devices Directive 93/42/EEC (as amended)

 KEMENTERIAN KESEHATAN REPUBLIK INDONESIA
DIREKTOMT JENDERAL KEFARMASIAN DAN ALAT KESEHATAN
Jalan H.R. Rasuna Said Blok X-5 lGvling 4 _ 9 lakarta 12950
Telepon : (021) 5201590 pesawat ZOZ1,BOIL
Faksimib : (021) 52964838 Kotak pos : 203

Berdasarkan :

Peraturan Menteri Kesehatan R,l No.1190/MenkeslPerNllll2}lO tanggal 23 Agustus 2010

tentang lzin Edar Alat Kesehatan dan Perbekalan Kesehatan Rumah Tangga dengan ini
diberikan persetujuan untuk diedarkan dengan :

NOMOR IZIN EDAR

ALAT KESEHATAN

KEMENKES RI AKL 20401412418

Nama SERENITY CO Analyzer Pro

Jenis Produk Carbon monoxide gas analyzer.

Kategori Produk Peralatan Anestesi

Sub Kategori Peralatan Anestesi Diagnostik

Type / Ukuran

Kemasan Unit

Nama Pabrik MD DIAGNOSTICS LTD., United Kingdom

Untuk SERENITY GLOBAL LTD., United Kingdom

Nama Pendaftar PT. SERENITY INDONESIA. DKI Jakarta

Atas dasar lisensidari

Ketentuan 1. Persetujuan izin edar berlaku sampai dengan 11 Februari2021.

2. Wajib menyampaikan laporan berkala setiap 1 (satu) tahun
terhadap jenis dan akibat efek samping dari produk yang
diedarkan.
3. lzin edar ini merupakan persetujuan perpanjangan dari nomor
pendaftaran AKL 204014124'18 tanggal 18 November 2014.
Dengan demikian izin edar yang lama tidak berlaku lagi.

Persyaratan 1. Apabila dikemudian hari ada pihak lain yang lebih berhak atas
nama keagenan diatas, sesuai dengan ketentuan yang berlaku,
pendaftar bersedia melepaskan nama keagenan produk tersebut.
2. Apabila dikemudian hari terdapat kekeliruan, maka persetujuan ini
akan ditinjau kembali.

09 Oktober 2017
a.n. Direktur Jenderal
Direktur Penilaian Alat Kesehatan dan PKRT

drg. Arianti Anaya, MKM

NlP. 1 9640924 199403 2 001