HAMILTON MEDICAL PN 260185 HAMILTON-BC8010 Breathing Circuit Set Instructions

HAMILTON MEDICAL PN 260185 HAMILTON-BC8010 Breathing Circuit Set

Breathing circuit diagram

1. Ventilator inspiratory limb
2. Humidifier chamber
3. Patient inspiratory limb, heated
4. Connector: OD10/OD10
5. Unheated inspiratory limb extension, for use in incubator
6. Y-piece adapter with sampling port OD10/OD10/ID15
7. Patient expiratory limb
8. T-piece OD10/ID10 with pressure line, 1.6 m
9. Elbow adapter, 90°: ID22/ID15/OD22
10. Leer connector, male, symmetrical (2×)
11. Soft adapter: ID15/ID10 (2x)
12. Straight connector: OD10/ID15 (2×)

Incubator and warming bed use

Conventions

Alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the device.

Alerts the user to the possibility of a problem with the device associated with its use or misuse, such as device malfunction, device failure, damage to the device, or damage to other property

Emphasizes information of particular importance.

Overview

The HAMILTON-BC8010 breathing circuit set (PN 260185) can only be used with the HAMILTON-H900 humidifier. For an overview of the breathing circuit set and its components, see page 2.

Intended use

The HAMILTON-BC8010 breathing set is intended to be used together with compatible Hamilton Medical respiratory gas humidifiers during invasive and noninvasive mechanical ventilation of pediatric and neonatal patients.

Safety information

• Reprocessing of Hamilton Medical single-use products can affect the product properties and may cause injury to the patient. For example, a change to the surface structure during reprocessing may lead to a change in the tear strength or cause actual cracking. Furthermore, an altered surface structure may result in, for example, a microbial aggregation of spores, allergens, and pyrogens, or cause an increase in the number of particles released as a result of chemical changes in the material properties.

• 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.

• The breathing circuit set must not be covered by any objects, such as sheets, towels, and so on.

• Use caution when positioning the breathing circuit. Place the breathing circuit in such a way that condensation cannot reach the patient.

• Follow hospital infection control procedures for all tests and use.

• Discard the product if it fails two subsequent preoperational checks or if there is any sign of damage.

• Adding attachments or other parts/ assemblies to a breathing system can change the pressure gradient across the ventilator, which can adversely affect ventilator performance and patient safety.

• Connect only a single breathing circuit at a time. Do not connect any circuit as an extension to another one. Doing so can seriously harm or kill the patient.

• Route the breathing circuit without tension and without any kinks from the ventilator or humidifier to the patient, and protect against unintended influences.

• Do not use heated breathing circuits without existing gas flow. If the gas supply is interrupted, the humidifier must be turned off or be in Standby mode.

• Do not touch the hot plate or the bottom of the chamber. The surfaces can reach a temperature of over 85°C. These hot surfaces radiate heat.

• Heated limbs must not be placed directly on the patient’s skin. Attach breathing circuits or tubing holders appropriately to avoid mechanical forces on the ET tube.

• Only fill the humidifier chamber with sterile, demineralized water that meets the hospital’s hygiene requirements.

• Do not operate the device if the water level in the humidifier chamber exceeds the marked maximum.

• Check the breathing circuit for condensation regularly and drain if required.

• The humidifier must always be positioned below patient level. Do not operate the humidifier at an angle in excess of 10°.

• Do not use this breathing circuit set with humidifiers other than HAMILTON-H900.

• During high-frequency oscillation (HFO), regularly check the patient condition and ventilation settings, and refer to the HFO device Operator’s Manual.

• (USA only) Federal law restricts this device to sale by or on the order of a physician.

• Check the breathing set for damage prior to use. Discard the breathing set if there is any sign of damage.

• Handle used products as contaminated goods according to local laws and regulations or hospital internal procedures.

• The temperature symbol on the temperature probe must always face up and be visible.

• Use the unheated limb extension only inside the incubator.

• Always place the heated limb with the temperature probe outside the incubator.

• Before use, read the HAMILTON-H900 Humidifier Instructions for Use.

• The refill water should not be warmer than 37°C.

• Follow the Instructions for use of the corresponding ventilator when using a pressure line.

• Ensure that the water supply to the humidifier chamber is functioning properly.

• Set the appropriate ventilator alarms.

• Do not apply pressure to the water reservoir once the water refill has automatically stopped and the water has reached the maximum level.

• Ensure the humidifier is placed in Standby or turned off before disconnecting any components.

• Do not add any drugs or medication directly to the water in the water chamber. If the HAMILTON-H900 is used in combination with any medical gases or nebulized medications, follow the Instructions for use of the supplied application and make sure that it is suitable for use with active humidification.

• Use the stickers provided to indicate the date on which to replace the breathing circuit set.

• Check the stability of all connections, prior to use.

• Incompatible parts can result undegraded performance, which can affect safety

About the breathing circuit and breathing circuit sets

The breathing circuit comprises the limbs with integrated heater wire and integrated temperature probe. The breathing circuit set comprises the breathing circuit and the humidifier chamber with water feed line.

4 Connecting the breathing circuit

Note that the limb connectors on the humidifier combine electrical connections with breathing circuit connectors. Ensure proper orientation of electrical contacts on the breathing circuit connectors to match the connecting element on the humidifier.
For an overview of the breathing circuit set and its components, see page 2.

To connect the breathing circuit set to the humidifier

1. Insert the humidifier chamber completely into the humidifier until it clicks into place.
   To remove it, pull the humidifier chamber out of the humidifier.

2. Connect the ventilator inspiratory limb first to the humidifier, and then to the inspiratory port on the ventilator.

3. Connect the ventilator expiratory limb to the expiratory port on the ventilator and the Y-piece.

4. Connect the patient inspiratory limb first to the humidifier chamber, and then to the Y-piece.

5. Insert the humidifier chamber water feed spike into the water reservoir.

Delivery

The components are delivered clean and ready for clinical use.

Disposal

A used component 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.

Technical specifications

Luer connector, male, symmetrical (2x)
Compliance (at 60 cmH2O)| 1.3 ml/cmH2O
Smallest internal diameter| 800 ml
Water volume (min/max)| 80 ml / 200 ml
Flow resistance (at 2.5 l/min) Inspiratory: Expiratory| 0.03 cmH2O/(l/min) 0.02 cmH2O/(l/min)
Flow resistance (at 15 l/min) Inspiratory: Expiratory:| 0.06 cmH2O/(l/min) 0.04 cmH2O/(l/min)
Gas leakage (at 60 cmH2O)| < 30 ml/min
Maximum operating pressure| 20 kPa
Circuit length| 1.65 m (approx. 5.5 ft)
Compatibility| HAMILTON-H900 humidifier
Operating temperature| Recommended: 18°C to 26°C (65°F to 78°F)
Storage temperature| -20°C to 60°C (-4°F to 140°F)
Storage and operating humidity| 5% to 95% relative humidity, noncondensing
Maximum operating duration:| 28 days
Conforms to| IEC 60601-1:2005/ A1:2012 ISO 80601-2- 74:2017 EN ISO 5356-1:2015 EN ISO 5367:2014 IEC 62366-1:2015 ISO 10993-1:2018 ISO 13485:2016

1. All values presented are worst case scenarios
2. Internal diameter (ID) and outer diameter (OD) in mm.
3. 15 mm and 22 mm conical connectors according to ISO 5356-1.

Symbols on device and packaging

See page 46.

| Quantity
---|---
| Follow the Instructions for use
| Do not reuse
| Applicable to neonatal/pediatric patient groups
| Do not use if packaging is damaged
| Do not use any blades, knives, or cutters to open; they can damage the product
| Medical device
| To patient inspiratory port
| From patient expiratory port
| Filling level mark on humidifier chamber
| EurAsian Conformity (EAC) mark
| Restricted use of hazardous substances in electronic and electrical parts
| For use in incubator
| For use in warming bed
| Temperature probe. Marks the location of the temperature probe on the breathing circuit.
| CE Marking of Conformity, seal of approval guaranteeing that the device is in conformance with the Council Directive 93/42/EEC concerning medical devices

Customer Support

For devices manufactured in Switzerland
Manufacturer
Hamilton Medical AG
Via Crusch 8, 7402 Bonaduz, Switzerland
+41 58 610 10 20
info@hamilton-medical.com
www.hamilton-medical.com
medin Medical Innovations GmbH
Adam-Geisler-Str. 1
82140 Olching
Germany

Documents / Resources

| HAMILTON MEDICAL PN 260185 HAMILTON-BC8010 Breathing Circuit Set [pdf] Instructions
PN 260185 HAMILTON-BC8010 Breathing Circuit Set, PN 260185, HAMILTON-BC8010 Breathing Circuit Set, Breathing Circuit Set, Circuit Set, Set
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References

• medical.com is for sale | www.brandforce.com
• Hamilton Medical - Intelligent Ventilation since 1983

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