CooperSurgical, Inc. Contents CONTENTS SECTION 1 – PREFACE Copyright SECTION 2 - SAFETY WARNINGS Glossary of Safety/Information Symbols SECTION 3 - PRODUCT OVERVIEW Unpacking and Inspection Accessories Optional Equipment Intended Use General Description SECTION 4 - BASIC OPERATION Features and Operation Assembling the R65 Connection to the Mains Start of Apparatus...
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Contents CooperSurgical, Inc. CONTENTS St.St Heat A-ST Hour Rest SECTION 6 - CARE AND MAINTENANCE Cleaning Preparation at the Point of Use Periodic Cleaning Disinfection Drying Calibration Disposal of electrical and electronic equipment. SECTION 7 - TROUBLESHOOTING SECTION 8 - TECHNICAL DATA SECTION 9 - WARRANTY INFORMATION AND LIMITS ON LIABILITY SECTION 10 - RETURNING PRODUCT Returned Goods Policy...
Section 1 CooperSurgical, Inc. Preface SECTION 1 – PREFACE Copyright This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, otherwise copied or distributed, completely or in part, without the approval of CooperSurgical, Inc. Users of K-SYSTEMS CooperSurgical, Inc products should not hesitate to contact us if there are any unclear points or ambiguities in this manual.
Section 2 Safety Warnings CooperSurgical, Inc. SECTION 2 - SAFETY WARNINGS Glossary of Safety/Information Symbols Source: ISO 15223-1 and ISO 60601-1 Symbol Meaning In accordance with Low Voltage Directive 2014-35-EU CooperSurgical.com 0120 Consult instructions for use - coopersurgical.com Hard copies available on request Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be presented on the medical device itself.
Section 3 CooperSurgical, Inc. Product Overview SECTION 3 - PRODUCT OVERVIEW Unpacking and Inspection • Unpack the equipment. • Check the packing list to insure all accessories are there. • Examine the packing material carefully for separately packed items. • Check the warming plate for external surface damage.
Product Overview CooperSurgical, Inc. Intended Use The K-SYSTEMS R65 Trolley is intended to maintain the temperature of gametes and/or embryos during assisted reproductive technology (ART) treatments. General Description The stainless steel surface maintains a preset temperature in the range ambient to max 42°C. The temperature is electronically controlled and can be read on the display in increments of 0.1°C.
Section 4 CooperSurgical, Inc. Basic Operation SECTION 4 - BASIC OPERATION Features and Operation Assembling the R65 No assembly needed. Just follow directions below and the unit is now ready for use. Connection to the Mains The mains voltage is automatically regulated to the correct level by the mains adaptor (PSU). Connect the R65 to the mains supply using the enclosed PSU.
Section 4 Basic Operation CooperSurgical, Inc. Temperature Setting and Control The display indicates the average temperature of the surface. Action Press set-point key until set temperature is shown. Press and hold set-point key. While holding the set-point key in, press either the arrow UP or arrow DOWN key to raise or lower the set temperature.
Section 4 CooperSurgical, Inc. Basic Operation Temperature Alarm The temperature alarm indicates too high or too low temperature. The alarm will be activated if the temperature rises or falls more than 0.5°C from the set point. There will be an acoustic signal and the red LED light in the alarm key will be activated.
Section 5 Menu Function CooperSurgical, Inc. SECTION 5 - MENU FUNCTION The user can access a number of advanced functions via the menu. Action Display Press and hold UP+DOWN key for 3 seconds to enter the menu. The first option “UNIT” will appear in the display. Press UP/DOWN key to navigate within the Menu.
Section 5 CooperSurgical, Inc. Menu Function Overview of Options ˚C Send UNIT Version 3 ˚F RS232 Off +0.05 Tn-t -0.05 Calib. value +0.05 Tn-b -0.05 Calib. value +0.1 INT.T -0.1 M + 1 Ti.St H + 1 M + 1 St.St H + 1 HEAT...
Section 5 Menu Function CooperSurgical, Inc. Unit In the UNIT option the displayed temperature unit can be set to either degrees Celsius or Fahrenheit. Follow these steps to navigate in the UNIT option. Action Display Press and hold UP+DOWN key for 3 seconds to enter the menu.
Section 5 CooperSurgical, Inc. Menu Function RS232 The RS232 output was intended for data-logging and third-party monitoring, but is no longer supported by CSI. The steps below are provided for reference only. Follow these steps to navigate in the RS232 option. Action Display Press and hold UP+DOWN key for 3 seconds to...
Section 5 Menu Function CooperSurgical, Inc. Tn-t/Tn-b The Tn-t/Tn-b option is for calibration of the displayed temperature of the table top (Tn-t) and the drawer (Tn-b). If there is an offset between the value on the display and any measurements made with a high precision external temperature sensor, this can be corrected.
Section 5 CooperSurgical, Inc. Menu Function TI.St The Ti.St (Time Set) option is for setting the time. Follow these steps to navigate in the Ti.St option. Action Display Press and hold UP+DOWN key for 3 seconds to enter the menu. The option “UNIT”...
Section 5 Menu Function CooperSurgical, Inc. St.St The St.St (Start Set) option is the timer function for the heat. By using this option, time can be saved as the R65 can be ready for use before procedures start in the morning. Note: This function will only work correctly if the clock is set.
Section 5 CooperSurgical, Inc. Menu Function Heat The HEAT option is used for the heater to turn on at a certain time. Note: This function only works in conjunction with St.St. If St.St is set to 8.00 and heat function is on, the heater will automatically turn on at 8.00 using 24 hour clock.
Section 5 Menu Function CooperSurgical, Inc. A-ST The A-St (Automatic Start) option is used to repeat the timer (St.St) function every day of the week. Note: This function works in conjunction with St.St and HEAT. If St.St.is set to 8.00 and heat function is on, the heater will automatically turn on at 8.00 every day.
Section 5 CooperSurgical, Inc. Menu Function Hour The HOUR option gives the opportunity to show the time on the display when the heat is off. Follow these steps to navigate in the HOUR option. Action Display Press and hold UP+DOWN key for 3 seconds to enter the menu.
Section 5 Menu Function CooperSurgical, Inc. Rest The REST function will restore all factory set values. Any changes made to the displayed temperature, unit readings and controller value will be reset. Note: Calibration value in the TUNE option will remain and not be reset. Follow these steps to navigate in the REST option.
Section 6 CooperSurgical, Inc. Care and Maintenance SECTION 6 - CARE AND MAINTENANCE Cleaning Periodic cleaning is recommended as part of routine maintenance. Disinfection is also recommended for media spills, visual accumulation of dust, and other evidence of contamination. Clean and disinfect the surfaces when necessary and immediately after any media spills. Cleaning and disinfection should be performed with the equipment switched off.
Section 6 Care and Maintenance CooperSurgical, Inc. Disposal of Electrical and Electronic Equipment. CooperSurgical have taken the necessary steps to comply with the EC directive 2012/19/EU on waste electrical and electronic equipment (WEEE). Environmental implications: WEEE contains materials that are potentially hazardous to the environment and to human health.
Section 7 CooperSurgical, Inc. Troubleshooting SECTION 7 - TROUBLESHOOTING Symptom Cause Action Temperature more than ±0.5°C Check the set temperature. Wait Temperature alarm is on. from set temperature. for the temperature to stabilize. No heating. Set-point below ambient. Change set-point (e.g. 37°C). No mains supply.
Section 8 Technical Data CooperSurgical, Inc. SECTION 8 - TECHNICAL DATA Material Stainless steel Weight 25Kg Overall dimensions (WxDxH) 664x581x760mm Table plate 661x493mm Warming area 450x380mm Temperature range Ambient to 49.9°C Temperature accuracy +/- 0.3°C Temperature set/read Digital LED display Power consumption 240W Heating...
Section 9 CooperSurgical, Inc. Warranty Information & Limits on Liability SECTION 9 - WARRANTY INFORMATION AND LIMITS ON LIABILITY CooperSurgical, Inc. warrants the operational safety and correct system operation of the whole unit under the condition that: • The device is operated as described in the manuals •...
Section 10 Returning Product CooperSurgical, Inc. SECTION 10 - RETURNING PRODUCT Please refer to the ‘Troubleshooting’ section in this manual before returning product to CSI. If the problem continues, please follow these instructions: Returned Goods Policy Goods will be accepted for return for the following reasons: •...
Section 11 Customer Service Contact Information CooperSurgical, Inc. SECTION 1 1 - CUSTOMER SERVICE CONTACT INFORMATION European Service Representatives ORIGIO a/s Knardrupvej 2 2760 Måløv Denmark Tel: +45 46 79 02 02 Fax: +45 46 79 03 02 New Purchases: E-mail: sales@coopersurgical.com Service Related E-mail: service@origio.com...
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