Vali it of t e ocu entation This manual describes the Carilex® VT • One suction pump. It is part of the device documentation. Do not pass this device to a third party without these Instructions for use.
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Instructions for Use | Carilex® VT • One About this document Infor ation of t e anufacture anufacturer Carilex Medical Inc. No.77, Keji 1st Rd., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.) Counseling and consultation service: Contact infor ation Carilex Medical UK Unit 14 &...
C ec oints efore usin VT • One Insert canister to t e VT • One Connect t e VT • One tu in connector to Carilex ressin it tu in connector Turn t e unit On Off T era...
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Instructions for Use | Carilex® VT • One Ta le of Contents rror In icators rror in icators lication of ne ati e ressure oun t era lication of e ati e ressure oun T era isinfection an cleanin isinfection an cleanin...
An operator (surgical supplier, health insurance, clinic, etc.) is any legal person, which owns the Carilex® VT • One suction pump and uses it, or on whose behalf the device is in use. The operator is responsible for providing a safe device and to instruct the user properly on the operation and the use of the device.
The Carilex® VT • One suction pump is made according to the current state of the art and is reliable. However, hazards may arise during the use of this device if it is operated by untrained personnel or it is not operated as described in these instructions for use.
Inten e use Carilex® VT • One is indicated for patients who benefit from wound management Intended use therapy via the application of negative pressure wound therapy for removal of fluids and excess exudates, infectious material, and tissue debris, which may promote wound healing.
Instructions for Use | Carilex® VT • One ortant notes for safe use Contrain ications Contraindicated for patients with the following conditions: • Presence of necrotic tissue • Malignancy • Untreated Osteomyelitis • Untreated malnutrition • Exposed arteries, veins, nerves, or organs •...
Instructions for Use | Carilex® VT • One ortant notes for safe use (3)Do not use the VT • One suction pump in a Hyperbaric Oxygen Therapy (HBO) when disconnected from the unit. (4)The device may be used in the event that defibrillation is needed, provided there is no electrical connection between the patient and the device.
Instructions for Use | Carilex® VT • One ortant notes for safe use ar in s an certi cation references Certificates, standards, guidelines: The device is a medical product class IIa in the sense of the (MDD) 93/42/EEC and class II in the sense of 21 CFR 878.4780.
Instructions for Use | Carilex® VT • One ortant notes for safe use afet infor ation an s ols of t e Instructions for use The safety instructions in this manual are marked with symbols and key words. Signal words like WARNING, CAUTION or ATTENTION designate the classification of the risk.
Instructions for Use | Carilex® VT • One ortant notes for t e safe use ols on t e e ice The following symbols are attached to the control unit of the negative pressure wound therapy. Conformity marking: confirms the conformity in accordance with the guidelines of the EU.
If the device has been dropped into water; If obvious defects might restrict safe operation (7)In any case, remove the power supply adapter from the electrical socket and have the unit checked by qualified personnel authorized by Carilex® Medical Inc.
Instructions for Use | Carilex® VT • One eli er an stora e ac a in The VT • One suction pump is supplied sturdy cardboard packaging. All packaging materials are recyclable and can be separated: Packing: Cardboard, waste paper o els Art.
Instructions for Use | Carilex® VT • One e ice an functional escri tion e ice escri tion o er unit The Power unit 1 is used as the housing for the compressed air unit as well as the compressed air system and also features: •...
Instructions for Use | Carilex® VT • One e ice an functional escri tion unctional escri tion Carilex® VT • One suction pump is a Negative Pressure Wound Therapy device that has been prescribed by your healthcare provider. This device has shown that it may help promote the healing of several different kind of wounds.
Instructions for Use | Carilex® VT • One re aration to et starte ols on t e is la Battery status Low Power Canister full Leakage Indicator Blockage Indicator Blockage Indicator when indication is disabled Call for service Mute Panel locked...
Instructions for Use | Carilex® VT • One re aration to et starte The battery must be fully charged prior to first use of the VT • One suction pump. If therapy unit is in warehouse / inventory and not used for more than three months, the battery needs to be recharged.
Instructions for Use | Carilex® VT • One re aration to et starte ressin Only Genuine Carilex Dressing Kits are to be used in conjunction with the VT • One system and must be in sterile condition. Carilex Dressing Kits should be applied in accordance with the Dressing Kit Instructions for Use, supplied with the dressings.
Please make sure the level markers on the VT • One is on the same side as the display screen. Connect t e VT • One tu in connector to Carilex ressin it tu in connector and screw tightly to ensure airlock.
Instructions for Use | Carilex® VT • One O eration roce ure Pressure setting for Continuous mode ( Disable blockage/leakage indicator should be under physician or qualified medical caregiver's order. In the event of disabled (1)When the screen shows , press...
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Instructions for Use | Carilex® VT • One O eration roce ure na le isa le t e loc a e alert in icator Press simultaneously for 3 seconds during therapy mode, Press to select modes until the following symbol appears on the display:...
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Instructions for Use | Carilex® VT • One O eration roce ure Enable/ Disable the leakage alert indicator Press simultaneously for 3 seconds during therapy mode. Press to select modes, until the following symbol appears on the display: Press to select the sensitivity of leakage indicator or disable the leakage indicator.
Instructions for Use | Carilex® VT • One O eration roce ure eturn Press to mute the pump when acoustic signals occur. When the pump is operating in CONTINUOUS MODE, press to adjust pressure level. When the pump is operating in INTERMITTENT MODE, press to adjust pressure level.
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Instructions for Use | Carilex® VT • One rror In icators rror In icators If VT • One suction pump detects any of the following situation, the light for display screen always turns on and acoustic warning signal sounds simultaneously. By pressing the mute key, the acoustic indicator is suppressed.
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Instructions for Use | Carilex® VT • One lication of t e e ati e ressure oun T era lication of t e e ati e ressure oun T era C UTIO Compliance with the hygiene regulations! asic cleanin The components of the Negative Pressure Wound Therapy are not supplied in a sterile condition.
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Instructions for Use | Carilex® VT • One isinfection an cleanin In order to prevent cross-contamination, the disinfection and cleaning of the entire Negative Pressure Wound Therapy must be carried out between use with different patients. If there is a notifiable disease according to the Federal Law concerning Epidemics, a hygiene expert must be consulted if necessary prior to the disinfection and cleaning.
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Instructions for Use | Carilex® VT • One isinfection an cleanin isinfection an Cleanin iene re uire ents of t e The operator must be notified about the measures which apply to the Negative o erator Pressure Wound Therapy and the actual hygiene directives for the disinfection.
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Instructions for Use | Carilex® VT • One Care an aintenance Ins ection The safe operating condition of the Negative Pressure Wound Therapy has to be checked at each use by the operator (the competent medical trading partner) or during the use by the patients at least once in a year in particular with regards to the following: •...
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Instructions for Use | Carilex® VT • One Trou les ootin Trou les ootin c art Problem Inspection procedure Possible solution 1. Check if power cord is firmly plugged 1. Secure power cord into wall socket into wall outlet Power unit does not function 2.
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Instructions for Use | Carilex® VT • One Tec nical ata Classi cation Tec nical ata Control unit Medical device ............Class IIa (comply with 93/42/EEC ............ Class II (comply with 21 CFR 878.4780) Model ................. VT • One Dimensions ..............15 x 8.5 x 5 cm Weight (with empty canister) ............
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Instructions for Use | Carilex® VT • One lectro a netic Co ati ilit This equipment has been tested and found to comply with the limits for medical device to IEC 60601-1-2-2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
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Instructions for Use | Carilex® VT • One lectro a netic Co ati ilit ui ance an anufacturer s eclaration electro a netic i unit The VT•One, S1004 is intended for use in the electromagnetic environment specified below. The customer or the user of the VT•One, S1004 should assure that is used in such environment...
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Instructions for Use | Carilex® VT • One lectro a netic Co ati ilit en e se aration istance et een orta le an o ile unications e ui ent an t e VT•One The VT•One, S1004 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Instructions for Use | Carilex® VT • One U-2S1004-30121-G V1.0...
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