MicroVention TERUMO IFU100127 V-Grip Detachment Controller Instructions
- July 17, 2024
- MicroVention TERUMO
Table of Contents
MicroVention TERUMO IFU100127 V-Grip Detachment Controller
FAQ
- Q: Can the V-Grip Detachment Controller be reused?
- A: No, the V-Grip Detachment Controller is designed for single-use only to prevent risks of infection and ensure proper functionality.
- Q: What should I do if I need to use the V-Grip Controller with other equipment?
- A: If using the V-Grip Detachment Controller with other equipment is necessary, ensure proper observation to verify normal operation. Maintain a distance of at least 30 cm between the V-Grip Controller and Portable RF communications equipment.
INTRODUCTION
Refer to the HydroCoil™ Embolic System and MicroPlex™ Coil System Instructions for Use for instructions regarding use of the V-Grip™ detachment controller with the V-Trak™ delivery pusher.
- During detachment, the light should flash and the beep should be intermittent
- The model number is VG501
- The input voltage is 9V
- The battery type is 9V
INTENDED PURPOSE
The V-Grip Detachment Controller is intended for use with the HydroCoil Embolic System and MicroPlex Coil System only. It should be used to detach the HydroCoil Embolic Coils and MicroPlex Coils as described in the HydroCoil Embolic System and MicroPlex Coil System IFU’s.
PRECAUTIONS
WARNINGS AND PRECAUTIONS
- Do NOT use in conjunction with radio frequency (RF) devices. Portable and mobile RF communications equipment can affect Medical Electrical Equipment.
- Do not use the V-Grip Controller adjacent to or stacked with other equipment because it could result in improper operation. If such use is necessary, V-Grip Detachment Controller and the other equipment should be observed to verify that they are operating normally.
- Maintain a distance of at least 30 cm (12 inches) between the V-Grip Detachment Controller and Portable RF communications equipment.
- If the V-Grip Detachment Controller is re-used on another patient it can lead to the risk of patient infection.
SPECIFICATIONS And EMC COMPLIANCE
- The V-Grip Detachment Controller is a single-use Type BF Applied Part.
- Do not operate the V-Grip Detachment Controller in an environment with temperature exceeding 40 °C or relative humidity exceeding 75%.
- The V-Grip Detachment Controller has been designed to meet the EMC requirements of EU and FDA. Compliance was demonstrated by meeting the following test limits of IEC 60601-1-2.
ELECTROMAGNETIC EMISSIONS
The V-Grip Detachment Controller is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment.
Emissions Test| Compliance| Electromagnetic Environment
RF emissions CISPR 11| Class B| The V-Grip does not use RF energy for its
internal function. Therefore, it is unlikely to cause any interference in
nearby electronic equipment.
ELECTROMAGNETIC IMMUNITY
The V-Grip Detachment Controller is intended for use in the electromagnetic environment specified below. The user should ensure that it is used in such an environment.
Immunity Test| IEC 60601 Test Level| Electromagnetic Environment
Electrostatic Discharge
IEC 61000-4-2
| 2,4,6 and 8 kV (±) Contact Discharge 2, 4, 8 and 15 kV (±) Air Discharge|
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30%.
Radio Frequency Electromagnetic Field Amplitude Modulated
IEC 61000-4-3
| 80 MHz to 2.7 GHz
3 V/m up to 10 V/m
80% AM 1 kHz
| Radio frequency electromagnetic field should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
Proximity Field from Wireless Transmitters IEC 61000-4-3| 385 MHz: 27 V/m @ 18
Hz pulse modulation 450 MHz: 28 V/m @ FM modulation
710 MHz, 745 MHz, 780 MHz: 9 V/m @
217 Hz pulse modulation
810 MHz, 870 MHz, 930 MHz: 28 V/m @
18 Hz Pulse modulation
1720 MHz, 1845 MHz, 1970 MHz: 28 V/m @
217 Hz Pulse Modulation
2450 MHz: 28 V/m @ 217 Hz Pulse modulation
5240 MHz, 5500 MHz, 5785 MHz: 9 V/m @
217 Hz Pulse modulation
| Wireless transmitters used in the field should be characteristic of a
typical location in a typical commercial or hospital environment.
Power Frequency Magnetic Field IEC 61000-4-8| 30 A/m (Both 50 Hz and 60 Hz
field)| Power frequency magnetic fields should be at levels characteristic of
a typical location in a typical commercial or hospital environment.
PACKAGING AND STORAGE
Store at a controlled room temperature in a dry place. Keep away from
sunlight.
Do not ship and store in an environment with temperature exceeding 60 °C or
relative humidity exceeding 75%.
Visually inspect all the sterile barrier systems, that are labeled as sterile,
immediately prior to use. Do not use if breaches in sterile barrier system
integrity are evident, such as pouch is damaged, open.
After use, dispose the V-Grip Detachment Controller in accordance with
hospital, administrative and/or local government policy and in accordance with
Waste Electrical and Electronic Equipment Directive (WEEE).
- This V-Grip Detachment Controller has battery removal and disposal capability. Using a flathead screwdriver or similar tool, push down on the battery cover tab to open the housing and remove the battery. Dispose of the battery in a manner consistent with hospital, administrative and/or local regulations.
- Dispose of the V-Grip detachment controller housing in accordance with hospital, administrative and/or local regulations.
MRI SAFETY INFORMATION
The V-Grip Detachment Controller is MR Unsafe.
Caution: Federal law restricts this device to sale by or on the order of a Physician.
Caution: Users and/or patients should report any serious incidents that have occurred in relation to the device to the manufacturer and the competent authority of the member state or the local health authority in which the user and /or patient is established.
WARRANTY
MicroVention, Inc. warrants that reasonable care has been used in the design and manufacture of this device. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether expressed or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning, and sterilization of the device as well as factors relating to the patient, diagnosis, treatment, surgical procedure, and other matters beyond MicroVention, Inc.’s control directly affect the device and the results obtained from its use. MicroVention, Inc.’s sole obligation under this warranty is limited to the repair or replacement of this device through its expiration date. MicroVention, Inc. shall not be liable for any incidental, indirect, special, or consequential loss, damage or expense directly or indirectly arising from the use of this device.
MicroVention, Inc. neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this device. MicroVention, Inc. assumes no liability with respect to devices reused, reprocessed or resterilized and makes no warranties, expressed or implied, including, but not limited to, merchantability or fitness for intended use, with respect to such device. Prices, specifications, and model availability are subject to change without notice.
CONTACTS
Manufacturer:
- MicroVention, Inc.
- 35 Enterprise Aliso Viejo, CA 92656 USA
- Tel: 714.247.8000
- www.microvention.com
Authorized European Representative:
- MicroVention Europe SARL 30 bis, rue du Vieil Abreuvoir 78100 Saint-Germain-en-Laye France
- Tel: +33 (0)1 39 21 77 46
- Fax: +33 (0)1 39 21 16 01
© Copyright 2023 MicroVention, Inc. All rights reserved.
MicroVention™, MicroPlex™, V-Grip™, HydroCoil™, and V-Trak™ are trademarks of
MicroVention, Inc., registered in the United States and other jurisdictions.