IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
Manually operated by 1 person.
Handle = hand-operated suction device.
Manual aspiration pump with finger activated vacuum release valve.
Vacuum indicator (mmHg, in Hg, kPa, bar).
Screw thread to attach the fluid trap, non-autoclavable.
Anterior suction cup autoclavable at 121°C.
Diameter: 5cm.
Height: 2cm.
Plastic fluid trap cup with lid.
Containing a disk attached with wire.
O-ring on the edge autoclavable at 121°C.
Aspiration tube.
With inner tubing connecting the fluid trap to the cup.
Autoclavable at 121°C.
Length: 19cm.
Supplied with:
2 pumps/handles.
1 cup.
2 belt disks.
1 trap assembly (lid and cup).
2 tubes.
2 belts.
2 O-rings for Trap
1 x Instructions for assembly, use and maintenance, and list of accessories and spare parts with product reference code, in 3 languages (English, French and Spanish) with DVD
Accessories/Spare parts/Consumables:
Spare parts:
1 pumps/handles.
1 cup.
1 belt disks.
1 trap assembly (lid and cup).
1 tubes.
1 belts.
1 O-rings for Trap
Instructions for use:
Place the cup safely and correctly over the flexion point of the fetal head.
Exert the traction in line with the pelvic axis to correct malpositions of the foetal head so the optimal birth canal diameter and autorotation will occur naturally.
The traction is delivered by pressing the thumb- of finger-activated vacuum release valve.
This detachable Fluid Trap and vacuum stem must be cleaned, disinfected after each use, and sterilised in a steam steriliser. (Palm Pump must not be included in this sterilization).
Packaging & Labelling:
Primary packaging
Unit presentation: 5 (five) OmniCup w/traction force indicator + box with Manufacturer's instruction for use, spare parts and accessories.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address of supplier (manufacturer)
- Extra information required: Number of units per secondary packaging.
Symbols used according ISO 15223
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 I device
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Environmental requirements:
Not use PVC polymers
These technical specifications are generic and may vary depending on the selected Vendor.
Product description:
Manually operated by 1 person.
Handle = hand-operated suction device.
Manual aspiration pump with finger activated vacuum release valve.
Vacuum indicator (mmHg, in Hg, kPa, bar).
Screw thread to attach the fluid trap, non-autoclavable.
Anterior suction cup autoclavable at 121°C.
Diameter: 5cm.
Height: 2cm.
Plastic fluid trap cup with lid.
Containing a disk attached with wire.
O-ring on the edge autoclavable at 121°C.
Aspiration tube.
With inner tubing connecting the fluid trap to the cup.
Autoclavable at 121°C.
Length: 19cm.
Supplied with:
2 pumps/handles.
1 cup.
2 belt disks.
1 trap assembly (lid and cup).
2 tubes.
2 belts.
2 O-rings for Trap
1 x Instructions for assembly, use and maintenance, and list of accessories and spare parts with product reference code, in 3 languages (English, French and Spanish) with DVD
Accessories/Spare parts/Consumables:
Spare parts:
1 pumps/handles.
1 cup.
1 belt disks.
1 trap assembly (lid and cup).
1 tubes.
1 belts.
1 O-rings for Trap
Instructions for use:
Place the cup safely and correctly over the flexion point of the fetal head.
Exert the traction in line with the pelvic axis to correct malpositions of the foetal head so the optimal birth canal diameter and autorotation will occur naturally.
The traction is delivered by pressing the thumb- of finger-activated vacuum release valve.
This detachable Fluid Trap and vacuum stem must be cleaned, disinfected after each use, and sterilised in a steam steriliser. (Palm Pump must not be included in this sterilization).
Packaging & Labelling:
Primary packaging
Unit presentation: 5 (five) OmniCup w/traction force indicator + box with Manufacturer's instruction for use, spare parts and accessories.
The following should appear on the packaging:
- Designation of the instrument.
- Name and address of supplier (manufacturer)
- Extra information required: Number of units per secondary packaging.
Symbols used according ISO 15223
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 I device
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Environmental requirements:
Not use PVC polymers
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $889.32 |
