Adult/pediatric flow sensor, single use
281637, 282049, 282092, 282051
Instructions for use
PN 624269/12 | 2021-10-15
Adult/Pediatric Flow Sensor Single Use
 | Follow the Instructions for use | ||
 | Conformity with Medical Device Regulation (EU) 2017/745 | ||
 | Applicable to adult/pediatric patient groups | ||
 | Do not reuse |  | MR safe |
| QTY | Quantity |  | Medical device |
 | Do not use if package is damaged | ||
Instructions for use adult/pediatric, flow sensor, single use281637, 282049, 282092, 282051
WARNING
- Hamilton Medical single-use products may release material particles, microbiological substances, and biomolecular structures if they are reprocessed, and may endanger atients. The product properties are affected by both physical and chemical processes. A mechanical change to the material properties can lead to the release of an increased number of particles and changes to the surface structure that can cause cracks. Furthermore, a changed surface structure can lead to an aggregation of germs, spores, allergens, endotoxins, and pyrogens.
- Hamilton Medical does not assume any warranty for the proper function of single-use items if they are reprocessed and reused by the user. Any liability on the part of Hamilton Medical for any damages resulting from the use of reprocessed or reused single-use parts, or use of any non-Hamilton Medical accessories and consumables, is excluded.
CAUTION
(USA only): Federal law restricts this device to sale by or on the order of a physician.
NOTICE
- Replace the flow sensor in accordance with hospital infection control procedures, or depending on the patient’s secretions and nebulization of medication, if required.
- Follow internal hospital infection control procedures.
- Visually inspect the flow sensor body, tubing, and internal flap. Discard the flow sensor if there is any sign of damage.
- Calibrate the flow sensor prior to patient use. lf calibration fails, it may be repeated once. The flow sensor must be discarded if calibration fails the second time.
Intended use
The Hamilton Medical flow sensor is a device to measure patient airflow with Hamilton Medical ventilators.
Ventilator connection
Connect the blue and clear flow sensor tubes to the same-colored flow sensor connectors on the ventilator. Blue to blue, clear to white/silver.
Patient connection
Insert the flow sensor between the Y-piece of the patient circuit and the patient connection. The end of the flow sensor marked Patient faces the patient. Use a short section of flexible tubing between the flow sensor and the patient connection.
Tubing clip
The clip is designed to secure the flow sensor’s sensing tubes to the breathing circuit. Always leave a loop of tubing from the clip to the flow sensor to accommodate the full range of patient movement.
Calibration
The flow sensor must be calibrated prior to patient use. To calibrate, follow the instructions in the appropriate ventilator Operator’s Manual.
Cleaning and disinfection
The flow sensor is delivered clean and ready for clinical use.
Disposal
Used flow sensors must be handled as contaminated. Follow all local, state, and federal regulations with respect to waste management and environmental protection when disposing of used parts.
Environmental requirements and storage conditions
Operating: -20°C to 50°C (-4°F to 122°F), relative humidity 5% to 95%, noncondensing.
Storage: -20°C to 60°C (-4°F to 140°F).
624269;12
For devices manufactured in Switzerland
Manufacturer/Hersteller/Fabricant
Hamilton Medical AG
Via Crusch 8, 7402 Bonaduz
(+41) 58 610 00 20
email: [email protected]
www.hamilton-medical.com
For devices manufactured and sold in the USA
Printed in the USA
Manufactured for/Hergestellt für/Fabriqué pour
Hamilton Medical AG
Via Crusch 8, 7402 Bonaduz (+41) 58 610 00 20
email: [email protected]
www.hamilton-medical.com
Distributor in USA/Handelsvertretung in den USA/
Distributeur aux États-Unis
Hamilton Medical, Inc.
4655 Aircenter Circle, Reno, NV 89502(800) 426-6331 (toll free) (775) 858-3200
[email protected]
www.hamilton-medical.com
© 2021 Hamilton Medical AG
medin Medical Innovations GmbH
Adam-Geisler-Strasse 1
DE – 82140 Olching
624269;12
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