Product Description:
Mechanical, battery-less stopwatch (spring-wound timer) to assist medical staff to determine the respiration rate of newborns in the context of suspected acute respiratory infection diagnosis.
Timer is used for measuring newborn breathing by counting the number of breaths in 60 seconds.
The time count in seconds is easy to observe by the medical staff.
The watch has a rest button to the side of the winder.
Size: Pocket-size.
Material: Stainless steel.
Count-up or count-down.
Durable, water-resistant construction.
The watch is activated by with an easily accessible button.
Operated in temperature from -15°C to +60 °C.
Supplied with:
Manufacturer's instructions for use, cleaning and maintenance in English, French and Spanish.
Calibration certificate.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Battery-less timer is used for measuring newborn breathing by counting the number of breaths in 60 seconds.
Packaging and Labelling:
One (1) unitn protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
Regulation and Conformity Reguirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485 or ISO 9001 certified.
Safety and Product Standards (current versions of the following standards):
ISO 3158: Timekeeping instruments - Symbolization of control positions.
ISO 1112: Horological movement jewels.
ISO 6426: Horological vocabulary
ISO 10552: Timekeeping instruments - Crowns and sealed tubes - Designs and dimensions.
Environmental Requirements:
ISO 14001: Environmental management systems
Mechanical, battery-less stopwatch (spring-wound timer) to assist medical staff to determine the respiration rate of newborns in the context of suspected acute respiratory infection diagnosis.
Timer is used for measuring newborn breathing by counting the number of breaths in 60 seconds.
The time count in seconds is easy to observe by the medical staff.
The watch has a rest button to the side of the winder.
Size: Pocket-size.
Material: Stainless steel.
Count-up or count-down.
Durable, water-resistant construction.
The watch is activated by with an easily accessible button.
Operated in temperature from -15°C to +60 °C.
Supplied with:
Manufacturer's instructions for use, cleaning and maintenance in English, French and Spanish.
Calibration certificate.
Accessories / Spare Parts / Consumables (available but not supplied):
N/A
Intended use:
Battery-less timer is used for measuring newborn breathing by counting the number of breaths in 60 seconds.
Packaging and Labelling:
One (1) unitn protective packaging with a label that includes:
Device identity and intended purpose.
Manufacturer's product code or reference number.
Manufacturer identification.
Address of the manufacturing site.
EC Rep identification.
How the device should be used, maintained and stored.
Lot/Batch and MFD.
Any residual device risks, warnings, limitations or contraindications.
Symbols used according ISO 15223.
CE mark.
Regulation and Conformity Reguirements:
CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent.
Declaration of Conformity according to ISO 17050.
ISO 13485 or ISO 9001 certified.
Safety and Product Standards (current versions of the following standards):
ISO 3158: Timekeeping instruments - Symbolization of control positions.
ISO 1112: Horological movement jewels.
ISO 6426: Horological vocabulary
ISO 10552: Timekeeping instruments - Crowns and sealed tubes - Designs and dimensions.
Environmental Requirements:
ISO 14001: Environmental management systems
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $6.56 |
