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Creo Medical 7-EMR-050 Instructions For Use Manual
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Creo Medical 7-EMR-050 Instructions For Use Manual

Electrosurgical generator
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Instructions for
Biomedical Use
Electrosurgical
Generator
CAUTION: Federal law restricts this device to sale by or on the order of a physician
Reference (model): 7-EMR-050. Language: English.
Verfügbar in Deutsch. Disponible en français. Disponible en español
Disponibile in italiano. Beschikbaar in het Nederlands
For use with Creo Medical Ltd accessories and surgical instruments only.
Explanations of symbols, wordings and definitions
Yellow symbol.
General Warning
This device generates
non-ionizing radiation.
Do not remove the cover.
Blue symbol. Consult
Accompanying
Documents
Defibrillator-Proof Type
CF Applied Part
Manufacturer
Date of Manufacture
Reference (model)
number
Serial number
UL Classification Mark
(applicable only if this is
on the generator rear
E464226
panel)
Proprietary & Confidential - Page 1 of 29 - Uncontrolled if Printed
Do not use if package is damaged
Packaging contains one unit
Instrument can be broken or
damaged if not handled carefully
Keep away from sunlight
Keep dry
Temperature limitation
Humidity limitation
Atmospheric pressure limitation
Caution – Generator detected
fault or error when the red
indicator above this symbol is
illuminated
Page 1 of 28

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Summary of Contents for Creo Medical 7-EMR-050

  • Page 1 Reference (model): 7-EMR-050. Language: English. Verfügbar in Deutsch. Disponible en français. Disponible en español Disponibile in italiano. Beschikbaar in het Nederlands For use with Creo Medical Ltd accessories and surgical instruments only. Explanations of symbols, wordings and definitions Yellow symbol.
  • Page 2 Explanations of symbols, wordings and definitions Do not dispose of the Mains inlet power supply Electrosurgical Generator in fuses normal waste Equipotentiality CE marking for the generator 2797 Settings for cutting COAG Settings for coagulation function function Cutting Waveform Active Coagulation Waveform Active Medical Device MR Unsafe...
  • Page 3 “Instructions for Use, Electrosurgical Generator”. The Electrosurgical Generator delivers radiofrequency (RF) electrosurgical and microwave energy (MW) and is for use only with appropriate Creo Medical Ltd accessories. Microwave energy operation is outside the scope of Intended Use by the Biomed Department.

  • Page 4: Safety Instructions

    Use this Electrosurgical Generator only with appropriate Creo Medical Ltd Biomed Test Pack specified for use with this Electrosurgical Generator. Use of non- Creo Medical Ltd accessories may lead to a risk of serious injury to the operator. Do not use the Electrosurgical Generator, a Biomed Interface Cable, a Biomed RF Test Cable, or a Biomed Footswitch Cable any of these appears to be damaged.
  • Page 5 Do not open the cover of the Electrosurgical Generator or modify hardware or software in any way. Servicing of the Electrosurgical Generator must only be performed by Creo Medical Ltd personnel or their designated representative. Modification or opening of the Electrosurgical Generator by unqualified persons may result in electrical shock and will violate the warranty of the Electrosurgical Generator.

  • Page 6: Rear Panel

    Device Description Front Panel On / Standby Button and Cut indicator LED (yellow) Coagulation indicator LED (blue) Warning indicator Microwave indicator LED (flashing blue) Symbol: Consult Symbol Defibrillation-proof type CF Accompanying Documents applied part + / - Control Buttons Output connection socket Menu control button Display Rear Panel...
  • Page 7 Biomed Generator Non-Clinical Use Accessories Biomed Test Pack – REF 7-PG1-301 The Biomed Test Pack is necessary for some verification of patient RF treatment output and detection of attachment of surgical accessories. 16. Biomed Footswitch Cable 2-PG1-187 17. Biomed Interface Cable 2-RS2-210 18.
  • Page 8 Set-up Warning The Electrosurgical Generator must always be connected to an AC power supply with a protective ground (earth). Do not connect the power supply cord (also referred to as an AC power cord) if it appears damaged or contaminated, if it has been modified, or if it does not meet the requirement specified in the product specification table in this Biomed Instructions for Use, as there is a risk of electrical shock to the patient or user.
  • Page 9 The table below identifies all the tests that may be performed by the Biomed user. The generator is initially provided from your Creo Medical Ltd representative in shipping packaging validated to assure arrival of the generator in a condition that is operational and safe for use.
  • Page 10 • pertinent. Free from missing, insecurely affixed or illegible labels. • Is marked with reference number: Inspect the 7-EMR-050 and has a (non-Biomed) generator Instructions for Use document present Remove Footswitch is footswitch from • Free from splits and cracks.
  • Page 11 Each generator is tested at 25 Amps for earth bonding continuity at time of manufacture. Earth bonding testing current amplitudes in the Biomed setting are according to local policies. For field checks Creo Medical Ltd employs the Rigel 288+ for the safety tests listed above.
  • Page 12 3. Verification of User Interfaces Language Selection and Verification of Status Indicators, Character Display and Display Buttons Event Biomed Action Acceptance Criteria Display LED Function Test Connect the generator to the wall mains supply mains supply; switch the On / Off Power (11) switched to On (‘1’...
  • Page 13 4. Verification of User Interfaces Verification of Clinical Footswitch Operation and Surgical Accessory Detection Event Biomed Action Acceptance Criteria Connect the generator to the wall mains supply mains supply; switch on at the rear rocker switch (11). Connect the clinical use footswitch to the generator Footswitch Connection Socket (13), the Biomed Interface Cable to the Output connection socket, and the...
  • Page 14 5. Verification of RF Output Maximum Power, Continuous RF Waveform and Audible Alarm Tone Verification Overview: This generator is verified for maximum RF capability making use of a Biomed access code entered by pressing the appropriate sequence of + / - Control Buttons (4) followed by the Menu Control Button (5).
  • Page 15 Verification of RF Output Figure 1: Rigel Uni-Therm Analyzer Settings for Automated RF Load Curve Sweep Figure 2: Rigel Uni-Therm Biomed Footswitch Cable Connections Figure 3: Rigel Uni-Therm Biomed RF Test Cable Connections Page 15 of 28 Proprietary & Confidential - Page 15 of 29 - Uncontrolled if Printed...
  • Page 16 Verification of RF Output Acceptance Event Biomed Action Criteria 1. Semi-automated RF load curve measurement: Rigel Uni-Therm Analyzer configuration: Connect the Biomed Footswitch Cable and the Biomed RF Test Cable to the Rigel Uni-Therm Analyzer for automated testing using the Uni-Therm internal load resistance and measurement device (MD) as shown in Figures 2 and 3.
  • Page 17 Testing the microwave power output Servicing – risk of injury or death. There are no user serviceable parts in the generator. Servicing should be performed only by suitably qualified persons in accordance with servicing information provided by the manufacturer. Incorrect servicing may result in faulty operation of the device and accessories and exposure to hazardous voltages and electrical currents that can cause death Testing the Microwave Power Output –...
  • Page 18 Keysightmodel E4418B Power sensor Keysightmodel E4412A High power attenuator NARDA 769A-30 Test cable Available from Creo Medical N-N type connector adaptor Available from Creo Medical QN to N adaptor Available from Creo Medical The test set-up is illustrated below. To enable accurate power measurement, the combined attenuation of the test cable, high power attenuator and connection adaptors must be known accurately at 5.8 GHz.

  • Page 19: Specifications

    Specifications For BIOMED RF and Microwave CAOG Waveforms refer to the PG1 Generator IFU (2-PG1-906) Figure 4: 200 W RF Load Curve Specification Page 19 of 28 Proprietary & Confidential - Page 19 of 29 - Uncontrolled if Printed...
  • Page 20 Specifications Product Specification Table Classification Under IEC 60601-1 Concerning Electrical Protection - Classification: Class 1. A protective earth connection must be provided Applied Part - Classification to IEC 60601:2005 Type CF. This is Defibrillator Proof. Environment for Operation Ambient Temperature: +10 °C to +30 °C (+50 °F to +86 °F) Relative Humidity: 20 % to 90 % non-condensing...
  • Page 21 Height 165 mm +/- 5 mm Dimensions: Width 400 mm +/- 5 mm Depth 458 mm +/- 5 mm Standards Compliance Basic Safety and Electrical Performance IEC 60601-1:2005 + A1 Collateral Standard, EMC IEC 60601-2:2014 High Frequency Surgical Devices IEC 60601-2-2:2017 Microwave Therapy Equipment IEC 60601-2-6:2012 Endoscopic Equipment...

  • Page 22: Essential Performance

    Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Electrosurgical System (model ref 7-EMR-050) including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 23 Specifications Emissions EN 55011, Level A Group 2 in non-treatment modes. Conducted Blue Pedal Activation - Group 2 (deliberate generation in 5.8 GHz ISM band). Emissions: Exceeds EN 55011 Level A during RF (400 kHz) activation of the treatment output. Exemption from compliance with EN55011 is in accordance with EN60601-2-2.
  • Page 24 Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Electrosurgical Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Electrosurgical Generator should ensure that it is used in such an environment. IEC 60601-1-2 Electromagnetic Environment –...
  • Page 25 Specifications Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Electrosurgical Generator is intended for use in the electromagnetic environment specified below. The customer or the user of the Electrosurgical Generator should ensure that it is used in such an environment. IEC 60601-1-2 Electromagnetic Environment –...
  • Page 26 Specifications Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Electrosurgical Generator The Electrosurgical Generator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Electrosurgical Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Electrosurgical Generator as recommended below, according to the maximum output power of the communications equipment.
  • Page 27 Specification section of these Instructions for Use. In the event of product failure please contact Creo Medical Ltd to arrange servicing or repair. Please do not send the product to Creo Medical Ltd (or its authorized agent) without first obtaining a Returned Merchandise Authorization (RMA) number.
  • Page 28 CE marking 2797 Creo Medical Ltd, Creo House, Beaufort Park, Beaufort Park Way, Chepstow, NP16 5UH, United Kingdom Tel: +44 (0) 1291 637300 Fax: +44 (0) 1291 606015 E-Mail: customerservice@creomedical.com Website: creomedical.com Creo Medical, S.L. Pol. Ind. Cordovilla D, n°1, 31191 Cordovilla (Navarra), Spain Tel.:...
  • Page 29 2-PG1-953 (DOC-3822) Ver. 1 Approved By: (CO-220427) PG1 & EMR IFUS R Chisholm/J Joyce Description IFU’s updated to have the correct details for our EU authorised representative. BOM updated to reflect up-issue of IFU version. Justification Although a change to labelling has been made, this is to rectify a MDR Audit Minor Non-Conformity and does not impact labelling compliance or product safety. Assigned To: Initiated By: Priority:...