Creo Medical 7-PG1-132 User manual

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Instructions for Use
Footswitch 7-PG1-132
For use with the Creo Medical CROMA Electrosurgical Generator
model 7-EMR-050 only.
Language: English
Creo Medical re-order product (model) reference 7-PG1-132.
Explanations of symbols
Manufacturer
Keep away from
sunlight
Date of Manufacture
Keep dry
Serial number
Humidity limitation
Reference (model)
number
Atmospheric pressure
limitation
Number of units
enclosed in box
Caution
Fragile, handle with care
Medical Device
CE mark
CSA mark
Blue symbol. Consult
Accompanying
Documents
Do not dispose in
normal waste
Caution: US Federal law
restricts this device to
sale by or on the order
of a physician
European Union
Authorised
Representative
Transportation, this symbol appears next to the symbols indicating
environment limitations during transportation

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Storage, this symbol appears next to the symbols indicating environment
limitations during storage before and between uses
Instructions for Use are supplied in an electronic format through the Creo Medical
website.
Intended Use
Footswitch model 7-PG1-132 is intended for use with the Creo Medical CROMA
Electrosurgical Generator model reference 7-EMR-050 only.
Safety instructions
These Instructions for Use contain essential information on the Footswitch. Before use,
study this document thoroughly and refer to it whenever in doubt. If you have any
questions regarding these Instructions for Use contact Creo Medical.
Please also refer to the instructions for use supplied with the Creo Medical
CROMA Electrosurgical Generator model reference 7-EMR-050 that provide
information on how to use the footswitch with the electrosurgical generator.
Caution
Risk of injury due to incorrect handling:
• the plug connections must not be subjected to mechanical loads;
• switch off and disconnect from the electrosurgical generator before cleaning or
maintenance work;
• the footswitch and connection cable are a tripping hazard.
Strong magnetic fields can result in unwanted influences that may affect footswitch
operation. Additionally, magnetically conducting materials are to be kept away from the
direct foot switch area.
The footswitch and its connection cable contain no user serviceable parts. Do not
attempt to disassemble, repair of modify the footswitch.
In the event of malfunction, do not use the footswitch. Contact Creo Medical Limited or
your local authorised distributor for service support.

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Connecting the Footswitch
The footswitch is connected to the footswitch connection socket on the rear panel of
the Electrosurgical Generator.
The Footswitch and the Electrosurgical Generator should be positioned such
that damage or accidental activation is avoided and that they do not present a
tripping hazard.
Please also refer to the manufacturer’s instructions for use that are supplied
with the electrosurgical generator.
Maintenance
The Footswitch together with the Electrosurgical Generator require periodic preventive
maintenance every 12 months from the date of purchase. Servicing must only be
performed by Creo Medical personnel or their designated representative.
We recommend routine maintenance as follows:
• check enclosure and connecting cable for damage and destructive dirt;
• check functional elements and actuating elements for free operation.
Please also refer to the manufacturer’s instructions for use that are supplied
with the electrosurgical generator.
Cleaning
The footswitch should be cleaned before and after each use in accordance with
procedures or other requirements of the hospital or other clinical site.
Caution
Switch off the electrosurgical generator before cleaning:
• for manual cleaning only, use just a cloth impregnated with water and a mild
detergent;
• do not use cleaning agents which may damage the plastic surfaces such as strong
detergents, abrasive cleansers or solvent-based cleaners (such as benzine, stain
remover);
• during cleaning, avoid wiping with a cloth under the pedal, because this may cause
the springs to move out of position.

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Specifications
Type
Steute Technologies GmbH & Co. KG - MKF 2 1S/1S-MED GP26
Electrical Ratings
Switching voltage (UB): maximum 25 V AC / 60 V DC
Switching current (IB): maximum 1 A
Switching capacity (PB): maximum 15 W
Protection Class
IPX8 rating as per IEC 60529
Cable length
2,95 m shielded cable
Mechanical lifetime
>1,000,000 operations
Electrosurgical system compatibility
Creo Medical Limited CROMA Electrosurgical Generator, reference number 7-EMR-
050.
Environment for hospital/clinic storage prior to use and between uses
Store at room temperature in a clean and dry environment out of direct sunlight.
Temperature: 0°C to +30 °C (+32 °F to +86 °F)
Relative Humidity: *10 % to 90 % (noncondensing) - *20 % once unpacked
Atmospheric pressure 69 kPa to 106 kPa
Environment for operation
Temperature range +10 °C to +30 °C (+50 °F to +86 °F)
Relative Humidity 10 % to 90 %
Atmospheric pressure 80kPa to 106 kPa
Environment for transportation
Temperature range -20 °C to +50 °C (-4 °F to +122 °F)
Relative Humidity 10 % to 90 %
Atmospheric pressure 69kPa to 106 kPa

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Disposal
Disposal at end of service life.
Observe national, local and legal regulations concerning disposal.
Recycle each material separately.
Please contact Creo Medical Limited or your local distributor if you have any questions
concerning disposal.

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Creo Medical Ltd Creo House
Unit 2
Beaufort Park
Beaufort Park Way Chepstow, NP16 5UH UK
Tel: [phone]
Fax: [phone]
E-Mail: [email protected]
Albyn Medical, S.L.
Pol. Ind. Cordovilla D, n°1, 31191 Cordovilla (Navarra), Spain
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
Medical Electrical Equipment/Systems
IEC 60601-1 (Basic safety)
IEC 60529 (Degrees of protection)
IEC 60601-2-2 (High Frequency)
Document
Number
2-PG1-800-A
Revision
Date
03 Aug 2021
Ref: CO-210238