DOUBLEFLO INFLOW/OUTFLOW PUMP AND MANUAL

Organization name

HEMODIA SAS

SRN

FR-MF-000007191

Manufacturer status

Active

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

• CW999

  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), fluid extravasations, electric shock/burn, hemorrhage/bleeding, inflammation/redness, pain, nerve damage/ numbness, swelling/edema and minor tissue damage, user injury (unprotected moving pump heads), user contamination (blood, human debris), user contamination (through the environment), patient contamination, patient and user ethylene oxide contamination, blood poisoning, cross-contamination. There may also be complications such as a delay in the procedure and an increased anaesthesia time for the patient.
• CW999

  The DOUBLEFLO system is intended to be used in adult patients requiring arthroscopic procedure, regardless of gender. The use of the pump system is prohibided for pediatric population in European Union.
• CW999

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

  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). In 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.
• CW999

  The white silicone membranes from the two force sensors on the front panel of the pump have been designed for normal use and all misuses may lead to breakage of the pump which will no longer be covered by the warranty: • 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
• CW999

  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).
• CW999

  The use of the pump system is prohibided if arthroscopy is contraindicated.
• 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.
• CW999

  It is required to connect only DOUBLEFLO interface on the DOUBLEFLO pump. It is prohibited to connect another device than the DOUBLEFLO LINK on the C1 connector (9 pin connector). It is also prohibited to connect another device not approved by HEMODIA on the C2 connector (25 pin connector). The end user needs to control the correct connection of the interface (HCI, FCI, LINK, Footswitch) with the screw or the push pull lock. The metal sheet situated on the back of the pump has always to be kept closed by the screws (access reserved to the manufacturer).

Primary placement in France; available across 11 countries total.

Trade name

DOUBLEFLO INFLOW/OUTFLOW PUMP AND MANUAL

UDI-DI code

03661379266045

Basic UDI-DI

3661379FAB010002AE2

Reference / catalog number

72205776

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The DOUBLEFLO System is an arthroscopy system using saline bag fluid (0.9% NaCl). This arthroscopy system is intended for distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist, and for aspiration of fluids 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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• Expiration date
• Manufacturing date
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