Intended purpose of use: for uterine evacuation (manual vacuum aspiration) including treatment of incomplete abortion and induced abortion in early pregnancy.
Product description: Ipas MVA Plus is a plastic, lightweight MVA (manual vacuum aspiration) system.
Ipas MVA Plus Aspirator components:
Plunger, Cylinder, Valve Body, Collar Stop, O-ring, Buttons, Liner Clamp, Liner, Valve Cap.
A valve with 2 buttons (double valve) that control the vacuum, a cap and a removable liner.
Valve liner is removable by opening hinged valve body.
A plunger with a plunger handle and O-ring.
A 60cc cylinder for holding evacuated uterine contents, with a retaining clip for the collar stop.
A collar stop.
Material type: Polypropylene (latex free).
Capacity: 60 ml (60 cc).
Vacuum: 610-660 mm (24-26 in) Hg.
Non-sterile, Autoclavable, reusable.
Supplied with:
1 x tube of 2cc silicone.
The cap, collar stop and O-ring as components are suitable to be reused a maximum of 25 times.
Instruction for use:
Ipas MVA Plus aspirator requires high-level disinfection of sterilization (steam) prior to initial use and between patients. Detailed procedure for the management of Reusable MVA Instruments shall be available.
Aspirator must be suitable to be reused a minimum of 25-50 times under normal use and maintenance.
To be used with Ipas EasyGrip® Cannula, all sizes, no adapters needed (Cannula are sold separately).
Cannula must be high-level disinfected of sterile at the time of use.
Maintenance instructions shall have information about the following: Read carefully the IFU from the manufacturer. Cleaning, disinfection and sterilization as per manufacturer's instruction. Before use, reassemble, lubricate and check vacuum capability. The aspirator should be discarded and replaced for any of the following reasons of any other as applicable:
The cylinder is brittle of cracked of mineral deposits inhibit plunger movement.
The valve parts are cracked, bent of broken.
The buttons are broken.
The plunger arms do not lock.
The aspirator no longer holds a vacuum.
Storage conditions to be specified as below of as per manufactures instructions:
Store between 15 and 30°C.
Protect from sunlight and humidity.
Packaging & Labelling:
Unit presentation: 1 (one) MVA Ipas Aspirator with accessories.
Symbols used according ISO 15223.
Labelling shall be as per the regulations applied to the device.
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 IIa device.
Safety & product Standards: (All standards shall be current).
Must comply with the following standards:
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes.
ISO 14971 Medical Devices- Application of risk management to medical devices.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
Product description: Ipas MVA Plus is a plastic, lightweight MVA (manual vacuum aspiration) system.
Ipas MVA Plus Aspirator components:
Plunger, Cylinder, Valve Body, Collar Stop, O-ring, Buttons, Liner Clamp, Liner, Valve Cap.
A valve with 2 buttons (double valve) that control the vacuum, a cap and a removable liner.
Valve liner is removable by opening hinged valve body.
A plunger with a plunger handle and O-ring.
A 60cc cylinder for holding evacuated uterine contents, with a retaining clip for the collar stop.
A collar stop.
Material type: Polypropylene (latex free).
Capacity: 60 ml (60 cc).
Vacuum: 610-660 mm (24-26 in) Hg.
Non-sterile, Autoclavable, reusable.
Supplied with:
1 x tube of 2cc silicone.
The cap, collar stop and O-ring as components are suitable to be reused a maximum of 25 times.
Instruction for use:
Ipas MVA Plus aspirator requires high-level disinfection of sterilization (steam) prior to initial use and between patients. Detailed procedure for the management of Reusable MVA Instruments shall be available.
Aspirator must be suitable to be reused a minimum of 25-50 times under normal use and maintenance.
To be used with Ipas EasyGrip® Cannula, all sizes, no adapters needed (Cannula are sold separately).
Cannula must be high-level disinfected of sterile at the time of use.
Maintenance instructions shall have information about the following: Read carefully the IFU from the manufacturer. Cleaning, disinfection and sterilization as per manufacturer's instruction. Before use, reassemble, lubricate and check vacuum capability. The aspirator should be discarded and replaced for any of the following reasons of any other as applicable:
The cylinder is brittle of cracked of mineral deposits inhibit plunger movement.
The valve parts are cracked, bent of broken.
The buttons are broken.
The plunger arms do not lock.
The aspirator no longer holds a vacuum.
Storage conditions to be specified as below of as per manufactures instructions:
Store between 15 and 30°C.
Protect from sunlight and humidity.
Packaging & Labelling:
Unit presentation: 1 (one) MVA Ipas Aspirator with accessories.
Symbols used according ISO 15223.
Labelling shall be as per the regulations applied to the device.
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 IIa device.
Safety & product Standards: (All standards shall be current).
Must comply with the following standards:
ISO 13485 Medical devices -Quality management systems -- Requirements for regulatory purposes.
ISO 14971 Medical Devices- Application of risk management to medical devices.
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Environmental requirements: ISO 14001.
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $15.13 |
