BIS-5C01

Organization name

VEC MEDICAL SPAIN, S.L.

SRN

ES-MF-000002992

Manufacturer status

Active

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

• CW999

  Use the device with an appropriate electrosurgical generator. Recommended generators and settings are listed in Annex 1 of IFU
• CW999

  Examine the connections of all the electrosurgical generator accessories before use. Improper connections may result in arcing, sparking, accessory malfunction, or unwanted surgical effects. Low-frequency currents caused by electrical sparking between the electrodes and the patient's tissue may cause neuromuscular stimulation of the patient. If this occurs, the surgical procedure should be stopped, and the Instructions for Use of the generator consulted before proceeding.
• CW999

  Examine all devices to be connected to the electrosurgical generator. After connection, ensure that they are functioning as intended
• CW999

  DO NOT use COOLINGBIS® in the presence of flammable anaesthetics or nearby other flammable gases, fluids, or objects or in the presence of oxidizing agents, as fire could result.
• CW999

  Since the COOLINGBIS® device creates coagulations of several millimetres’ depth, it should not be used when superficial coagulations are requested or close to compromised structures (such as nerves or glands).
• CW999

  The COOLINGBIS® system is not indicated for cardiac or neurosurgical applications.
• CW999

  The device is not intended for contraceptive tubal coagulation (permanent female sterilization)
• CW999

  Do not use in newborn patients (up to 28 days after birth)
• CW999

  The surgical procedure must be performed by personnel with adequate training and preparation. Personnel should fully understand the nature and use of radiofrequency (RF) before performing electrosurgical procedures to avoid the risk of shock and burn hazards to both the patient and the operator and damage to instrumentation.
• CW999

  Make sure to position the device's electrical wire and all patient cables in a way to avoid contact with the patient or other cables
• CW999

  Irrigate the organ being treated with sterile saline to dissipate the heat if the organ temperature increases too much. Aspirate the serum before reapplying COOLINGBIS®.
• CW999

  Remove the blade guard carefully, without twisting or forcing it, to avoid cutting yourself or possible damages to the blade.
• CW999

  Avoid the blade hitting or getting in touch with other metallic elements. Place the electrode in a horizontal position on the surgical instrument table while the device is not in use.
• CW999

  When the COOLINGBIS® device is not in use during surgery, it should be placed in a clean, dry, non-conductive area that is not in contact with the patient. Accidental contact with the patient may cause burns (if activated by the foot pedal)
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Insulate the hollow viscera (stomach, small and large intestine) thermally with gauze to protect them from temperature increase and avoid contact with COOLINGBIS®, which could perforate them
• CW999

  Avoid contact between COOLINGBIS® and isolated vessels, if the vessel is not surrounded by parenchyma the application of RF with COOLINGBIS® could perforate it.
• CW010

  Consult the operating and user manuals of the RF generator, the peristaltic pump for the saline solution and any other ancillary devices for operating instructions, warnings and cautions prior to their use in the same surgical field as the COOLINGBIS® device.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW036

  Electrosurgical equipment emits high-frequency energy radiation. This may affect the operation of other medical equipment. To avoid interference, it is recommended not to use other energy devices at the same time (bipolar forceps, monopolar forceps, etc.) and to place the generator as distant as possible from other electrosurgical equipment. If two devices using power must be used at the same time, avoid contact between devices.
• CW999

  DO NOT USE out of the intended use
• CW999

  Avoid skin-to-skin contact points (e.g., between the patient’s arms and body), for example, by interposing dry gauze to ensure that contact does not occur.
• CW999

  The use of four (4) patient return electrode (PRE) pads is required for using this device (except for paediatric patients, in which the use could be reduced to three (3) PREs.). Ensure that all connections are safe and monitor closely to maintain appropriate contact between the PRE and patient skin during use. Consult PRE manufacturer's Instructions for Use for proper placement and use.
• CW999

  Electrosurgical equipment can affect the functioning of the monitors used during the procedure. Monitoring electrodes should be placed equidistant and as far as possible from the treated area.
• CW999

  Use the device with caution in the presence of pacemakers, as electrosurgical devices and accessories may cause interference with pacemakers or other active implants.

Primary placement in Spain; available across 8 countries total.

Trade name

not provided

UDI-DI code

08436570231919

Basic UDI-DI

843657023BISMK

Reference / catalog number

BIS-5C01

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Short monopolar electrosurgical electrode, 5 mm diameter, without blade, for coagulation in open surgery (COAG)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5 MU50
• Short

• K0201010301OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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