Component: |
Connectors: right angle F/M, straight F/M, straight M/M. |
|
Ayres T-piece. |
|
Reservoir bag with open-ended tail. |
|
Fresh gas supply tube. |
|
Reservoir tube and hose. |
Material: |
Polyethylene, low-density. |
|
Styrene butadiene (synthetic latex polymer) reservoir bag. |
Specifications: |
Reservoir bag: 500ml with open-ended tail. |
|
Reservoir tube: length 0.4m |
|
Fresh gas supply tube: length 1.6m with 15mm connector on fresh gas inlet |
|
Modified T-Ayres piece with 3 ports: |
|
- Fresh gas from an anaesthetic machine |
|
- Extension leads to a connector angled in the direction of the patient’s mask or endotracheal tube. |
|
- Extension leads to the reservoir tubing and bag. |
Connectors and adaptors: |
Right-angled connector (elbow) with Luer lock port - male end (M) 15mm towards T-Ayres piece and female end (F) 22M/15 towards the patient; can be removed to reduce dead space, when required. |
|
A straight male-to-male (M-M) connector and adaptor: between the reservoir bag and tube |
|
A straight female-to-male (F-M) connector or adaptor for the fresh gas inlet side; F with 15mm internal diameter. |
Unit presentation: |
1 sterile unit, in as single-use sealed bag or peel pack. |
|
Selling unit: 15 individual units. |
Packaging: |
Individually packaged in sealed plastic bags. |
|
Labelling: product description and reference number, lot number, manufacturing date, manufacturer’s name or logo, and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available. |
|
Each carton to be clearly marked with unit presentation and total content. |
Other: |
Meets following norms: |
|
EN 12342: Breathing tubes intended for use with anaesthetic apparatus and ventilators |
|
EN 1820:2005: Anaesthetic reservoir bags (ISO 5362:2000, modified) |
|
ISO 5362: specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung ventilator. |
|
EN 5356: Anaesthetic and respiratory equipment. Conical connectors Part 1: Cones and sockets |