IMPORTANT NOTE: These technical specifications are generic and may vary among suppliers.
Intended use: A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress.
Technical Specifications:
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
Diameter: 5cm.
Height: 2cm.
Plastic fluid trap cup with lid.
Containing a disk attached with wire.
O-ring on the edge
Aspiration tube.
With inner tubing connecting the fluid trap to the cup.
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
Single-use device
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 to ISO 15223
CE Mark
Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
Classification:
EU Medical Devices Directive 93/42/ECC, Class I / MDR
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2003 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
Intended use: A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress.
Technical Specifications:
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
Diameter: 5cm.
Height: 2cm.
Plastic fluid trap cup with lid.
Containing a disk attached with wire.
O-ring on the edge
Aspiration tube.
With inner tubing connecting the fluid trap to the cup.
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
Single-use device
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 to ISO 15223
CE Mark
Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) or EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
Note : For manufacturers which are supplying CE certificates and relevant documentation under the MDD, a declaration letter from the manufacturer that it is working towards compliance to MDR is required. Additionally, the manufacturer shall submit objective evidence to demonstrate compliance to MDR within one (1) year after supply awards have been given and signed. UNFPA reserves the right to change the probationary period of one year to an appropriate length of time which could be shorter than one year.
OR US FDA 510(K) clearance
Classification:
EU Medical Devices Directive 93/42/ECC, Class I / MDR
Safety & product Standards:
Must comply with the following standards:
ISO 13485:2003 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
| Pack Size | Avg. Price |
|---|---|
| Pack of 5 | $338.92 |
