Intended purpose of use: to carry out pressurized infusion/transfusion in emergency situations.
Product description:
Pneumatic cuff designed for 500/1000 ml infusion pouch/blood bags, to carry out pressurized infusion/transfusion in emergency situations.
Components:
- Cuff sleeve with net window and a pneumatic bag.
- Loop: rear suspension and front suspension
- Manometer pressure gauge
- Air-release valve
- inflation bulb
Material:
- cuff: tear proof cotton
- net: polypropylene.
- pneumatic bag, connecting tubes: rubber latex free
- bulb: polyurethane o rubber latex free
- pressure gauge and air-release valve: Stainless steel, chrome-plated
- pressure gauge membrane: Copper beryllium.
Specifications:
-Pressure cuff can be 500ml of 500 to 1000 ml
- Cuff: washable up to 60°C. Size approx. 35.5x 17 cm (inflated size 26x13cm)
- Reusable
Pneumatic bag with 2 side connections.
- tube to pressure gauge: approx. 7cm
- tube to bulb: approx.80 cm
Transparent net window: 25x15cm
Suspension system: 2 loops, one to maintain the container and the other to suspend the device from an infusion stand.
Dependent on manufacturer and cuff size the suspension system may vary slightly
Manometer:
- Diameter 49mm,
- Aluminium scale from 0 to 300 mmHG
Instructions for use:
used to carry out pressurized infusions of transfusions in emergency situations, for a 500-1000 ml infusion pouch of blood bags
make sure that pressure gauge is clear of any obstructions and allowed to move freely
Warming:
- rough handling of abuse may affect the gauge accuracy
Supplied with:
user and maintenance manual, warranty, in English.
Accessories/ spare parts/consumables:
- Manometer 300 mmHG.
- Inflator bulb with release valve
Packaging and labelling:
Individually wrapped in a plastic bag with a manufacturer manual
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol.)
CE mark
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.
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 Im device
Safety & product Standards:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
Product description:
Pneumatic cuff designed for 500/1000 ml infusion pouch/blood bags, to carry out pressurized infusion/transfusion in emergency situations.
Components:
- Cuff sleeve with net window and a pneumatic bag.
- Loop: rear suspension and front suspension
- Manometer pressure gauge
- Air-release valve
- inflation bulb
Material:
- cuff: tear proof cotton
- net: polypropylene.
- pneumatic bag, connecting tubes: rubber latex free
- bulb: polyurethane o rubber latex free
- pressure gauge and air-release valve: Stainless steel, chrome-plated
- pressure gauge membrane: Copper beryllium.
Specifications:
-Pressure cuff can be 500ml of 500 to 1000 ml
- Cuff: washable up to 60°C. Size approx. 35.5x 17 cm (inflated size 26x13cm)
- Reusable
Pneumatic bag with 2 side connections.
- tube to pressure gauge: approx. 7cm
- tube to bulb: approx.80 cm
Transparent net window: 25x15cm
Suspension system: 2 loops, one to maintain the container and the other to suspend the device from an infusion stand.
Dependent on manufacturer and cuff size the suspension system may vary slightly
Manometer:
- Diameter 49mm,
- Aluminium scale from 0 to 300 mmHG
Instructions for use:
used to carry out pressurized infusions of transfusions in emergency situations, for a 500-1000 ml infusion pouch of blood bags
make sure that pressure gauge is clear of any obstructions and allowed to move freely
Warming:
- rough handling of abuse may affect the gauge accuracy
Supplied with:
user and maintenance manual, warranty, in English.
Accessories/ spare parts/consumables:
- Manometer 300 mmHG.
- Inflator bulb with release valve
Packaging and labelling:
Individually wrapped in a plastic bag with a manufacturer manual
Labelling on the primary packaging:
Name and/of trademark and address of the manufacturer..
Manufacturer's product reference.
Type of product and main characteristics.
Lot number prefixed by the word ""LOT""(of equivalent harmonised symbol, if applicable).
Information for particular storage conditions(temperature, pressure, light, humidity, etc., as appropriate (of equivalent harmonised symbol.)
CE mark
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.
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 Im device
Safety & product Standards:
ISO 13485 Quality management systems -- Requirements for regulatory purposes
ISO 14971 Medical Devices- Application of risk management to medical devices
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $78.19 |
