Drape, calibrated,non-sterile,PACK-100

GENERAL DESCRIPTION
Calibrated blood collection drape.

INTENDED USE
Designed specifically to support early diagnosis (trigger) of post-partum haemorrhage within obstetric care.

TECHNICAL SPECIFICATIONS
Collection area size at a minimum : 100 x 80 cm.
Drape material: Low-Density Polyethylene (LDPE)
Material should be sufficient rigid to avoid spillage sideways, or pooling of blood due to ripples in the material.
The drape has a mechanism or design that allows the “V-shaped calibrated pouch” to open and maintain its shape, directing catching blood into it without spillage.
The drape comes with straps which are to be tied around the patient’s waist to hold it in place.
The drape is easy deployable, without the material clinging to itself.
The drape is suitable for patients with a high BMI.
Free of latex and DEHP
The drape is non-sterile and single use.
The drape is equipped with a graduated collection pouch with a maximum capacity of 2000 ml.
The graduations are easily readable from a distance of 1.5 meters.
Graduations:
- up to 500ml: marked at 50ml intervals
- Between 500 - 1000ml: marked at 100ml intervals
Accuracy:
- up to 500ml: ± 50ml
- between 500ml - 1000ml: ± 100ml
The drape has built-in disposal straps that can be used to seal the blood collection pouch, preventing spills and allowing safe discarding in line with hospital protocols after use.
The drape is not equipped with a screen (filter), to avoid blood clots being excluded from measured blood loss volumes.

SHELF LIFE
3 years from date of manufacture.

ENVIRONMENTAL CONDITIONS
Preferred storage conditions: 0 - 25°C, however never exceeding 55°C.

WEIGHT AND VOLUME (Packaged)
Weight: 10 kg.
Volume: 17.3 dm³.

PACKAGING
Primary packaging: box -100 drapes
Secondary packing: No secondary packing. One pallet can contain 60 boxes.

COMPONENT OF A KIT
No

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

NOMENCLATURE
GMDN© Code: 61048
EMDN Code: T0210