IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Type of Immunoassay/ Intended Used:
to count the breath of children to detect acute respiratory infections
Description: ARI Timer, timer comes with a fixed 60 seconds' countdown to determine the respiration rate of newborns and young children for suspected acute respiratory infection diagnosis.
Easily accessible button located at the centre of the device and activation by pressing the button. One audible beep at the start and two audible beeps at the end of the cycle, 60 sec.
The unit does not make any sounds during the countdown, flashing red signal during countdown
Accuracy = ± 0.1 second.
The unit is battery powered and full batteries allow the unit to support 10 ,000 cycles of 60 seconds as a minimum.
Not replaceable battery
At the press of the start button:
1. the device produces an audible beep to indicate the countdown has started.
2. Provides red visual indicator informing the user that the device has been activated and is counting down (For example a flashing LED could indicate the unit is currently counting down.)
3. After 60 seconds is elapsed, a double audible beep produced, and the visual indicator stops indicting the unit has stopped counting down.
4. Pressing the button during an ongoing countdown reset the unit which means stop the countdown and the visual indicator.
A provision included to ensure that the battery is not connected to the internal circuit at the time of delivery. This to avoid unwanted activation, leakage of accidental short-circuit of the unit.
Operating conditions: 10 - 40°C / 85% RH.
Supplied with
1 x cord (lanyard) for wearing timer around the neck Instruction for use and maintenance in English, French and Spanish. Precautions for Use such as ""To ensure maximum battery life, store in cool dry place"" etc.
Packaging/labelling
Primary packaging: Unit of use.
One (1) Timer, respiration for ARI + instructions for use in English French and Spanish. Symbols used according to ISO 15223
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. Batch number, Information for storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonized symbol) and Information for handling.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Classification:
Classified under EU MDR 2017/745 as Class II device
Warranty: 2 yrs minimum from the date of shipping
Type of Immunoassay/ Intended Used:
to count the breath of children to detect acute respiratory infections
Description: ARI Timer, timer comes with a fixed 60 seconds' countdown to determine the respiration rate of newborns and young children for suspected acute respiratory infection diagnosis.
Easily accessible button located at the centre of the device and activation by pressing the button. One audible beep at the start and two audible beeps at the end of the cycle, 60 sec.
The unit does not make any sounds during the countdown, flashing red signal during countdown
Accuracy = ± 0.1 second.
The unit is battery powered and full batteries allow the unit to support 10 ,000 cycles of 60 seconds as a minimum.
Not replaceable battery
At the press of the start button:
1. the device produces an audible beep to indicate the countdown has started.
2. Provides red visual indicator informing the user that the device has been activated and is counting down (For example a flashing LED could indicate the unit is currently counting down.)
3. After 60 seconds is elapsed, a double audible beep produced, and the visual indicator stops indicting the unit has stopped counting down.
4. Pressing the button during an ongoing countdown reset the unit which means stop the countdown and the visual indicator.
A provision included to ensure that the battery is not connected to the internal circuit at the time of delivery. This to avoid unwanted activation, leakage of accidental short-circuit of the unit.
Operating conditions: 10 - 40°C / 85% RH.
Supplied with
1 x cord (lanyard) for wearing timer around the neck Instruction for use and maintenance in English, French and Spanish. Precautions for Use such as ""To ensure maximum battery life, store in cool dry place"" etc.
Packaging/labelling
Primary packaging: Unit of use.
One (1) Timer, respiration for ARI + instructions for use in English French and Spanish. Symbols used according to ISO 15223
Labelling on the primary packaging:
Name and/of trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. Batch number, Information for storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of equivalent harmonized symbol) and Information for handling.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note: For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485: 2016
Classification:
Classified under EU MDR 2017/745 as Class II device
Warranty: 2 yrs minimum from the date of shipping
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $6.56 |
