INSTRUCTIONS FOR USE
PMS651
100 Use Footswitch Ha ndle for: 4mm Aesculap, Berchtold, Erbe T Series, Eschmann
TD300, TD311, DS302 Sutter BM780, 3m cable
PMS652
100 Use Footswitch Ha ndle for: 8mm Bard, Birtcher, Bovie, Bowa, Conmed,
Eschmann, Medtrex, Valleylab, 3m cable!
PMS653
100 Use Footswitch Ha ndle for: 4mm (female) Aesculap/Berchtold/Erbe T
Series/Huttinger/Mar tin/Micromed/Siemens/Sutter BM780, 3m!
PMS654
100 Use Footswitch Ha ndle for: 5mm ACC (standard) ICC, Erbe V10, Karl Storz, 3m
cable!
PMS750
100 Use fingerswitch with blade electrode, AUTOClabel and punch, 3m cable (5m
cable models available)
PMS950
60 Use fingerswitch with blade electrode, AUTOClabel and punch, 3m cable (5m cable
models available)
RE-USABLE FINGERSWITCHES & FOOTSWITCH HANDLES
These instructions for use do not replace the user manual of the electrosurgical unit used.
Read the user manual of each and ask Prima Medical or your distributor in case of doubt.
Product Specifications
INTENDED USE
The Fingerswitch is intended to be used as the active Monopolar electrode in an
electrosurgery generator system. It is a re-usable instrument designed to effect cutting,
coagulation & ablation of soft tissues by means of targeted delivery of RF current.
INDICATIONS
The device is indicated for any application that requires the cutting, coagulation, ablation or
excision of soft tissues according to the surgeon’s preference and habit.
Prima, as a manufacturer, do not recommend a specific procedure.
CONTRAINDICATIONS
Any use of this instrument for tasks other than for which is it indicated, can lead to premature
wear, which may result in damage which may cause potential hazards to patients and users.
These devices should never be used when:
• The device fails the instructions for use inspection
• In the presence of flammable materials or gases
• When electrosurgical techniques are contraindicated.
• If the labelled expiry date has been exceeded
• If, during use, the performance or characteristics of the device change suddenly.
• No non-conductive holster is present to isolate active electrodes from the patient.
INSPECTION!
These devices should be inspected before each use. Visually examine the devices for
obvious physical damage. Including:
• Cracked, broken or otherwise distorted plastic parts/ insulations/coatings. !
• Broken or significantly bent connector contacts.!
• Damage including cuts, punctures, nicks, abrasions, unusual lumps, discoloration.!
• Damage or perforation to the sterile packaging!
ISSUE 1 PML-RUF-IFU 13/12/2017!
INSTRUCTIONS FOR USE
RE-USABLE FINGERSWITCHES & FOOTSWITCH HANDLES
SETUP AND USE !
1. Insert the electrode into the receptacle of the fingerswitch and remove the plastic cap. Ensure
that the connection is firm and that there is no play and that there is no exposed metal.
2. Connect the instrument and cord to the generator/footswitch only while it is in the “OFF” or
“STANDBY” mode. Failure to do so may result in injury or electrical shock to the patient or
operating room personnel.
3. The device is equipped with a standard 4mm male plug connector. To operate the monopolar
electrosurgical features, the buttons are used. For fingerswitch models, yellow activates CUT
functions and blue activates COAG function, as indicated in the diagram below. Footswitch
models vary dependent on the footswitch being used – refer to the manufacturer’s
instructions.
4. Test the functions of the device once connected through brief activation before patient
introduction.
5. During use, ensure that the device is not left on or near the patient when not active, as
portions of the device may still pose a risk of burns.
6. Check the active portion of the device regularly for soft tissue residues (eschar). Eschar has a
high electrical impedance and failure to remove it from the device may result in increased
patient scarring.
CAUTION
• This device is provided NON-STERILE. Ensure that it has been sterilised prior to use.
• A thorough understanding of the techniques and principles involved in electrosurgical
procedures is necessary to avoid burn or shock hazard to patient and/ or operator.
• Modification, including bending, is not recommended. In the event of the electrode bending,
Prima Medical electrode models whose product code is suffixed with “A” will accept gentle
modification up to 60 degrees, but the use of mechanical or metal instruments to do this may
cause damage and affect subsequent product performance.
• Always refer to the generator manufacturers’ operating instructions for the correct use of this
equipment. Always use the lowest power setting possible to achieve the intended clinical
effect and use brief, intermittent activation of the device.
• Always be mindful of the presence of EM fields in the operating theatre. NEVER use the
device in proximity to any active implants. This may cause severe patient injury.
• If at any time the performance of the device changes suddenly, stop usage immediately.
• Keep the desired voltage/power as low as possible and use only brief intermittent activation in
order to minimize the potential for capacitive coupling and inadvertent burn injuries whilst
working at high voltages.
• Activate only when in contact / proximity to target tissue to avoid the possibility of unintended
tissue damage.
• Do not activate in close proximity to other active instruments, as this may cause insulation
breakdown.
• This product may be used only by trained medical staff, who use it according to the
instructions for use. A thorough understanding of the techniques and principles of
electrosurgery is ESSENTIAL for patient safety.
ISSUE 1 PML-RUF-IFU 13/12/2017!
INSTRUCTIONS FOR USE
RE-USABLE FINGERSWITCHES & FOOTSWITCH HANDLES
ADVERSE REACTIONS or SIDE-EFFECTS
The use of these devices may generate harmful “surgical” smoke. The presence of a suitable
smoke evacuation system during theatre use is recommended to minimise the risk of harm. !
SAFETY TIPS
• Use lowest possible power settings on the electrosurgery generator capable of producing the
desired surgical affect and use brief, intermittent activation of the device.!
• Never allow the cable to come in to contact with the skin of the patient or the operator during
electrosurgical activations.
• Do not permit the cable to be parallel and/ or in close proximity to the cables of other
electrosurgical devices.
• Always place unused electrosurgical accessories in a safe, insulated location such as a
holster/ quiver when not in use.
• Do not lay any device on the patient, especially one that has just been used. After using the
Cut or Coagulation function on an electrosurgical pencil, the tip/electrode is hot. This is to
prevent the patient, physician and/or staff from accidental burns and to prevent the possible
incidence of fires
WARNING!
CONNECT BIPOLAR ACCESSORIES TO THE BIPOLAR RECEPTACLE AND MONOPOLAR
ACCESSORIES TO THE MONOPOLAR RECEPTACLE. DO NOT ATTEMPT TO
INTERCHANGE BIPOLAR AND MONOPOLAR ACCESSORIES AS IMPROPER
CONNECTION OF ACCESSORIES MAY RESULT IN HAZARDOUS CONDITIONS.!
CLEANING & DISINFECTION
Never use an ultrasonic cleaning device! Use a soft bristle brush or damp cloth with mild
detergent to thoroughly wash and remove any foreign material and debris. Always follow the
detergent manufacturer recommendations for use. Then, use a disinfectant solution suitable
for the disinfection of surgical instruments. Finally, the device should be rinsed using warm
water and dried with a lint free cloth, with visual checks to ensure all material, detergent and
disinfection residues have been removed.
STERILISATION
DO NOT USE GAMMA TO STERILISE THIS DEVICE. DOING SO RISKS PRODUCT
FAILURE, ELECTRICAL BREAKDOWN AND SERIOUS INJURY.
Moist Heat Sterilisation
134 º C to 137 º C for > 3 minutes or
121 º C to 124 º C for > 15 minutes, depending on sterilisation equipment cycles
EtO Sterilisation
Follow manufactures recommendations appertaining to the sterilisation equipment used.
Only use validated equipment/processes according to national/international standards.
LIMITED WARRANTY
Prima Medical Ltd warrants that this product will be free from material and workmanship
defects. The warranty is void should Prima Medical Ltd determine that damage has occurred
as a result of improper handling, misuse, unauthorised repair or accident.!
ISSUE 1 PML-RUF-IFU 13/12/2017!
INSTRUCTIONS FOR USE
RE-USABLE FINGERSWITCHES & FOOTSWITCH HANDLES
!
DIAGRAM
SYMBOLS AND MEANINGS
Prima Medical Limited
Mill16, Bath Trading Estate
Stroud, Gloucestershire
GL5 3QF United Kingdom
TEL:+44 (0) 1453 752626 EMAIL: sales@prima-medical.com!
ISSUE 1 PML-RUF-IFU 13/12/2017!
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