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Summary of Contents for KEEWELL FT2800
- Page 1 Blood and Infusion Warmer FT2800 Operator’s Manual ( E d i t i o n : 0 6 / 2 0 2 0 / E n ) K E E W E L L M E D I C A L T E C H N O L O G Y C O . , LT D...
- Page 2 IMPORTANT: • These instructions are an essential part of the device. • They must be kept in a suitable place near the device and should accompany the device if it is transferred to other users. • For proper and safe use of this device it is essential that the warnings and safety instructions, as well as the instructions for use are read and carefully observed by all users before first using the device.
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Page 3: Table Of Contents
CONTENT Description Manufacturer declaration Contraindication EMC declaration Warnings Symbols Safety instructions Technical data Appearance and panel Operating and storage conditions Safety characteristics Manufacturer liability Installation &operation procedure 20 Warranty conditions Maintenance Periodic inspections Trouble shoot... -
Page 4: Description
DESCRIPTION • The Blood and Infusion Warmer FT2800 can be used in all applications in which hypothermia of the patient through cold transfusions and infusion solutions is to be prevented. It is consisted of the main body, 2 flexible warming profiles, fastening unit and power cable. - Page 5 Operator’s Manual FT2800 KEEWELL conjunction with the FT2800. • The temperature shown in the display corresponds to the temperature of the warming profile. • The temperature of the fluid to be heated that is reached at the end of the warming section depends on various factors, such as, the fluid's input temperature, the flow rate, the set temperature, the ambient temperature, etc.
- Page 6 Operator’s Manual FT2800 KEEWELL Output temp 40.8 39.3 38.2 37.6 37.2 35.3 34.8 33.8 33.2 33.3 32.8 32.3 31.7 30.7 30.5 One Profile Dual Profile Flowrate ml/min Fig. 1: Typical starting temperature of the fluid that has passed through at different flow rates...
- Page 7 Operator’s Manual FT2800 KEEWELL Applied part The warming profile which is applied part of the medical device is type "BF". The electrical conductors in the warming profile have been insulated from the other parts of the medical device to such a degree that no current higher than the allowable PATIENT LEAKAGE CURRENT flows if an unintended voltage originating from an external source is connected to the PATIENT, and thereby applied between the PATIENT CONNECTION and earth.
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Page 8: Contraindication
Operator’s Manual FT2800 KEEWELL CONTRAINDICATION It is forbidden to be used on the severe cardiopulmonary dysfunction patients. The device may not be used to warm living organisms, objects. It is forbidden to use for heating the drug liquid which the normal effect would be influenced... -
Page 9: Warnings
Operator’s Manual FT2800 KEEWELL WARNINGS ▪ If the over-temperature alarm is triggered, the supply of liquid to the patient must be immediately stopped by disconnecting the connection tube to the patient. The medium being used in the device must no longer be administered to the patient. - Page 10 ▪ The overheating of the infusion fluid may be caused if the infusion flow is stopped while the warming profile is on heating. ▪ Only sterile consumable materials may be used in conjunction with the FT2800. ▪ Repairs and modifications to the device may only be carried out by persons or service centers authorized by Keewell.
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Page 11: Safety Instructions
Operator’s Manual FT2800 KEEWELL SAFETY INSTRUCTIONS The device must only be used in areas in which the electrical installations are in accordance with the rules and regulations in force. To avoid electrical shock, the device must only be connected to a properly grounded power source. - Page 12 Operator’s Manual FT2800 KEEWELL • If the fixing clamp is damaged and no longer assure safe clamping to the infusion stand. Should a malfunction be evident, suitable warning signs should be attached to the device to ensure that it cannot be used before necessary service and repair...
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Page 13: Appearance And Panel
Operator’s Manual FT2800 KEEWELL Appearance and Control Panel Infusion Stand Infusion Tubing Main Control Body LED Screen Connection Cable Warming Profile Control Panel Fig. 2: General illustration... - Page 14 Operator’s Manual FT2800 KEEWELL Set temperature Light on: warming profile on heating Actual temperature Heating time Flashing accompanied with acoustic alarm and heating is switched off⇨ sensor malfunction Flashing accompanied with acoustic alarm ⇨ temperature lower than 32˚C Flashing accompanied with acoustic alarm and heating is switched off ⇨...
- Page 15 Operator’s Manual FT2800 KEEWELL Key to choose Key to switch between test mode Celsius and Fahrenheit Key to set temperature up Key to set temperature down Key Standby/ Operating Fig.4: Illustration of the control panel (*The same indications for the symmetric units. The key and key for both uses.)
- Page 16 Operator’s Manual FT2800 KEEWELL • The device can be fixed to the infusion stand or other support by using the clamp at the back. • Only use infusion stands or supports which be capable of supporting a minimum of ten pounds (4.5 kg) and with a minimum 60cm diameter wheelbase.
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Page 17: Safety Characteristics
Operator’s Manual FT2800 KEEWELL SAFETY CHARACTERISTICS Low temperature information signal The low temperature information signal is activated when the temperature of the warming profile drops below 32°C. In this event the under - temperature LED indicator lights up accompanied with the acoustic signal. - Page 18 Operator’s Manual FT2800 KEEWELL Sensor malfunction alarm In the event of sensor malfunction, the indicator will light up, the “HEAT TEMP” area will display a “LL” code accompanied with acoustic alarm and the device will stop working. Return it to the supplier or the manufacturer for a service.
- Page 19 Operator’s Manual FT2800 KEEWELL The alarm system does not have to be verified. The alarm limits cannot be adjusted. The risk management process has found that a shutdown of the alarms is not meaningful, because it is desirable that the error (e.g. high temperature) is detected.
- Page 20 Operator’s Manual FT2800 KEEWELL Alarm overview Software high Hardware-high Sensor malfunction temperature alarm temperature alarm alarm Condition The high temperature The high temperature Self-test detects a alarm is triggered when alarm is triggered when sensor malfunction. the temperature of the...
- Page 21 Operator’s Manual FT2800 KEEWELL Resetting The alarm can only be The alarm can only be The alarm can only reset by pulling out the reset by pulling out the be reset by pulling mains plug. mains plug. out the mains plug.
- Page 22 Operator’s Manual FT2800 KEEWELL Information signals Low temperature information signal Condition If the temperature of the warming profile drops below 32°C (89℉). The audio low temperature signal is deactivated during the first 300 seconds after switching on. Consequence No consequence in relation to the function of the device.
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Page 23: Installation &Operation Procedure
Operator’s Manual FT2800 KEEWELL INSTALLATION AND OPERATION PROCEDURE Installation: Check whether the device is damaged. Please do not use it if any damage has been found. • Fix the device firmly to the infusion stand at the position of 20-30cm below the infusion/blood bag, using the clamp at the back, then screw the fastening screw. - Page 24 Operator’s Manual FT2800 KEEWELL Clamp Fastening Screw Fig. 5: Illustration of the fastening clamp...
- Page 25 Operator’s Manual FT2800 KEEWELL Operation procedure • Glide the roll clamp next to the drip bucket or at the end of the infusion tubing. • Empty the air in tubing to make infusion channel ready. • Take the primed infusion line at 2-3cm to the end of patient side to insert in the tail (small end) of the warming profile.
- Page 26 Operator’s Manual FT2800 KEEWELL Drip bucket Holder warming profile Head of the warming profile for in flowing End of the warming profile for out flowing Fig. 6: Illustration of the holder of warming profile...
- Page 27 Operator’s Manual FT2800 KEEWELL Shutting down the device • Press the key to enter http://www.biaozhi.net/eNews/news/200602/0031_0000000919.shtml STANDBY mode. • Release all pressure in the infusion system by switching off the pressure cuffs or infusion pumps. • Remove the consumable material from the warming profile and dispose it according to the relevant regulations.
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Page 28: Maintenance
Operator’s Manual FT2800 KEEWELL If the fault occurs again, the device must be inspected by a trained service technician. MAINTENANCE • Always keep the surface clean. • The device may only be cleaned by using a soft cloth and mild water-soluble cleaning agents or special cleaning agents for plastics. -
Page 29: Periodic Inspections
Operator’s Manual FT2800 KEEWELL PERIODIC INSPECTIONS Periodic inspections should be carried out at least every 12 months. • The device needs to be checked before use again after a long period of non-use. • Checking should be carried out after any big removal of the device. - Page 30 Operator’s Manual FT2800 KEEWELL then press the key to return http://www.biaozhi.net/eNews/news/200602/0031_0000000919.shtml to STANDBY mode. Press on the key and key simultaneous until the sign is flashing. The device is now in over-temperature alarm testing mode. The corresponding unit will heat up to 42°C. The over - temperature alarm should be triggered at a temperature of 42.1°C.
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Page 31: Trouble Shoot
Operator’s Manual FT2800 KEEWELL TROUBLE SHOOTING Fault Possible Causes Remedy Nothing illuminates ⚫ Lack incorrect ⚫ Check socket/fuse, compare on the panel power supply mains voltage with details on rating plate ⚫ Mains connection cable or mains plug defective ⚫ Call a service person ⚫... - Page 32 Operator’s Manual FT2800 KEEWELL ⚫ Call a service person the temperature drops down and turn on the device. If fault remain, →Defect on control unit ⚫ Sunlight, heating, ⚫ Select a different location air-conditioning, the temperature of warming profile exceed 42°C ⚫...
- Page 33 Operator’s Manual FT2800 KEEWELL temperature information signal: ⚫ The input temperature ⚫ Lower the flow rate or preheat of the fluid to be heated Lights up accompanied the fluid in another way is too low or the flow with acoustic alarm rate is too high.
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Page 34: Manufacturer Declaration
Operator’s Manual FT2800 KEEWELL MANUFACTURER’S DECLARATION The blood and infusion warmer FT2800 is a medical product as defined by Directive 93/42/EEC. This is documented with the CE mark. Notified Body: MEDCERT, Approval Number CE0482. KEEWELL hereby confirms that the FT2800 comply with Directive of the European... -
Page 35: Emc Declaration
EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions The FT2800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT2800 should assure that it is used in such an environment. - Page 36 EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The FT2800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT2800 should assure that it is used in such an environment.
- Page 37 5 cycles for 5 cycles interruptions, it is recommended 70 % U 70 % U that the FT2800 be powered from (30 % dip in U (30 % dip in U an uninterruptible power supply or for 25 cycles for 25 cycles a battery.
- Page 38 EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The FT2800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT2800 should assure that it is used in such an environment. Compliance Immunity IEC 60601 test Electromagnetic environment –...
- Page 39 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FT2800 is used exceeds the applicable RF compliance level above, the FT2800 should be observed to verify normal operation.
- Page 40 Recommended separation distances between portable and mobile RF communications equipment and the FT2800 The FT2800 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FT2800 can help prevent electromagnetic interference...
- Page 41 Operator’s Manual FT2800 KEEWELL For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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Page 42: Symbols
Operator’s Manual FT2800 KEEWELL SYMBOLS The following symbols may appear in this manual, on the device, or on it's accessories. Some of the symbols represent standards and compliances associated with its use. Caution: Consult accompanying documents 0482 CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. The body. - Page 43 Operator’s Manual FT2800 KEEWELL using the device. Increasing temperature setting Decreasing temperature setting Standby / Operating Testing Mode Switch key between Celsius and Fahrenheit Over - temperature alarm Low temperature information signal Sensor fault...
- Page 44 Operator’s Manual FT2800 KEEWELL Warming profile is switched on Temperature setting Warming time Defibrillation- protection Potential Equalization Conductor Side up Keep away from water Fragile...
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Page 45: Technical Data
Operator’s Manual FT2800 KEEWELL TECHNICAL DATA Model: FT2800 Power supply: 100 - 240VAC/50-60 Hz Power input: 2.1A/115VAC 1.2A/230VAC Fuse: 2×T4A/250V Type of protection against electric shock: Class I Degree of protection against electric shock: BF Applied part; Defibrillation-protected Degree of protection against ingress of liquids:... - Page 46 Operator’s Manual FT2800 KEEWELL Low temperature information signal: 32℃ (89℉) Warming up time: Less than 2 minutes, 23±2℃~36℃（73±4℉~97℉） Operating mode: Continuous MDD Classification: IIb according to rule 9 Dimensions: (LxWxH) 249×200×136mm Weight: 2.3kg WP-143505, length 1.4 m, for infusion tube 3.5-5mm(O.D.) Warming profile: WP-146505, length 1.4 m, for infusion tube 6-7mm(O.D.)
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Page 47: Operating And Storage Conditions
Operator’s Manual FT2800 KEEWELL OPERATING AND STORAGE CONDITIONS OPERATING Temperature: 5～30°C Relative humidity: ≤80 % , noncondensing Air pressure: 700～1060 hPa STORAGE Temperature: -10～55°C Relative humidity: ≤93 %, noncondensing Air pressure: 500～1060 hPa... -
Page 48: Manufacturer Liability
Operator’s Manual FT2800 KEEWELL MANUFACTURER LIABILITY The manufacturer and the supplier of the device reject all liability if: • the device is not used in accordance with the instructions for use • the operating personnel are inadequately qualified or are not sufficiently informed about... -
Page 49: Warranty Conditions
Operator’s Manual FT2800 KEEWELL WARRANTY CONDITIONS The manufacturer guarantees that any material or structural defect occurring within 24 months (except warming profile 12 months) from the date of purchase will be repaired free of charge. A claim under this warranty can only be made under the following conditions: •... - Page 50 Operator’s Manual FT2800 KEEWELL • • The operating personnel are inadequately qualified or have not been adequately trained to operate the device based on the instructions for use and the safety advice. • • The operator has not followed the instructions in the manual to check and maintain the device properly.
- Page 51 Operator’s Manual FT2800 KEEWELL Manufacturer KEEWELL MEDICAL TECHNOLOGY CO., LTD. Add: Xiananyi Industrial Zone, Pingzhou, Nanhai, Foshan, Guangdong 528251, P.R.China Tel: +86 757 86260855 Fax: +86 757 86260100 E-mail: info@keewell.cn www.keewell.com.cn Wellita International BV Add: Franciscuslaan 22, 9112 Sinaai-Waas, Belgium...