DOUBLEFLO INFLOW/OUTFLOW PUMP AND MANUAL

Organization name

HEMODIA SAS

SRN

FR-MF-000007191

Manufacturer status

Active

6 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Target population : 8-years-old or older pediatric and adults patients requiring an arthroscopic surgery, regardless of gender. Side effects : The known and possible side effects during arthroscopy procedure with a fluid management system are following : Emphysema, hematoma, reflex sympathetic dystrophy, deep venous thrombosis (DVT) and fluid extravasations.
• CW010

  Reading this manual is compulsory before any use of the pump, its accessories and its consumable tubing.
• CW999

  The use of the DOUBLEFLO system is prohibited whenever arthroscopy is disallowed. The equipment must only be used by personnel trained in arthroscopy procedures. This medical qualified staff must wear standard operating theater protective equipment (mask, gloves, gown, hood). All electro-medical devices have to be located in the non-sterile zone (except for the remote control). The user has to avoid contact with any liquid to the pump and its accessories during the operation.
• CW011

  Do not use abrasive tools or sharp objects (like knives, scalpels,...) to avoid to tear the white silicone membranes. Do not remove the irrigation tube set with pressure inside to avoid to deform the white silicone membranes.
• CW259

  Do not connect the device to an unearthed or poorly earthed source of power. In order to avoid any risk of electric shock, this equipment must only be connected to a power supply equipped with a protective earth. Do not remove the casing (risks of electrocution). n order to avoid any risk of fire, replace spent fuses with fuses of the same characteristics.
• CW999

  The system may be affected by electromagnetic interferences (EMI) generated by other instruments. EMI may occur if the system is used in the vinicity of Radio Frequency Identification (RFID) or High Resonance (HR) surgical equipment. Check that the other instruments used in the operating theater comply with electromagnetic compatibility (EMC) standard IEC 60601-1-2.

Primary placement in France; available across 14 countries total.

Trade name

DOUBLEFLO INFLOW/OUTFLOW PUMP AND MANUAL

UDI-DI code

03661379239049

Basic UDI-DI

B-03661379239049

Reference / catalog number

72205775F

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

The DOUBLEFLO system represents an arthroscopy system using fluid from saline bags (0.9% NaCl). This arthroscopy system is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities, and fluid suction during arthroscopy procedures.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z1202110201MOTORISED ARTHROSCOPIC SURGERY SYSTEMS

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