Related Manuals for KEEWELL FT1800
Summary of Contents for KEEWELL FT1800
- Page 1 Blood and Infusion Warmer FT1800 Operator’s Manual ( E d i t i o n : 0 6 / 2 0 2 2 / 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 3 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 5: Table Of Contents
CONTENT Description ..........1 Manufacturer’s declaration ...... 33 Contraindication ........5 EMC declaration ........34 Warnings ............ 6 Symbols ........... 41 Safety instructions ........8 Technical data .......... 44 Appearance and control panel ....9 Operating and storage conditions .... 46 Safety characteristics ....... -
Page 7: Description
DESCRIPTION • The Blood and Infusion Warmer FT1800 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, flexible warming profile, fastening unit and power cable. - Page 8 Operator’s Manual FT1800 KEEWELL conjunction with the FT1800. • 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 9 Operator’s Manual FT1800 KEEWELL Fig. 1: Typical starting temperature of the fluid that has passed through at different flow rates...
- Page 10 Operator’s Manual FT1800 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 11: Contraindication
Operator’s Manual FT1800 KEEWELL CONTRAINDICATION 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 after heating. It is forbidden to be used on the severe cardiopulmonary dysfunction patients. -
Page 12: Warnings
Operator’s Manual FT1800 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 13 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 FT1800. • Repairs and modifications to the device may only be carried out by persons or service centers authorized by Keewell.
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Page 14: Safety Instructions
Operator’s Manual FT1800 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 15: Appearance And Control Panel
Operator’s Manual FT1800 KEEWELL Appearance and Control Panel Infusion Stand Infusion Tubing LED Screen Control Panel Main Control Body Warming Profile Connection Cable Power Cable Fig. 2: General illustration... - Page 16 Operator’s Manual FT1800 KEEWELL Set temperature Light on: warming profile on heating Actual temperature Heating time Flashing accompanied with acoustic alarm and heating is switched off ⇨ sensor Flashing accompanied with malfunction acoustic alarm and heating is switched off ⇨ temperature higher than 42˚C...
- Page 17 Operator’s Manual FT1800 KEEWELL Key to set temperature up Key to set temperature down Key Standby/ Operating Key to switch between Celsius and Fahrenheit Fig.4: Illustration of the control panel...
- Page 18 Operator’s Manual FT1800 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 19: Safety Characteristics
Operator’s Manual FT1800 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 20 Operator’s Manual FT1800 KEEWELL 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. This alarm can be triggered when the temperature of the warming profile is below -5.0°C or above 45.0°C.
- Page 21 Operator’s Manual FT1800 KEEWELL temperature exceeds 42±1℃, 43±2℃ in faulty situations, the independent high temperature protection incorporated into the device will cut off the heating power. Over-heating may cause hemolysis and vessel hurt. Thus it is requested for the operator that in the event of any suspected malfunction while in operation to stop the supply of liquid immediately by disconnecting the tube to the patient.
- Page 22 Operator’s Manual FT1800 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 the alarm is triggered when sensor malfunction. temperature of the...
- Page 23 Operator’s Manual FT1800 KEEWELL plug. mains plug. out the mains plug. Visual signal The over - temperature The over - temperature indicator LED indicator lights LED indicator lights up, the “HEAT lights up TEMP” area will display a “LL” code...
- Page 24 Operator’s Manual FT1800 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 25: Installation And Operation Procedure
Operator’s Manual FT1800 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 26 Operator’s Manual FT1800 KEEWELL Fastening Screw Clamp Fig. 5: Illustration of the fastening clamp...
- Page 27 Operator’s Manual FT1800 KEEWELL Operation procedure • Glide the roll clamp next to the drip bucket and empty the air in tubing to make infusion channel ready.
- Page 28 Operator’s Manual FT1800 KEEWELL • Take the primed infusion tubing at 2-3cm to the end of patient side to insert in the tail (small end) of the warming profile. Afterwards move your thumb over the infusion tubing and press it gently into the groove towards the head (big end) of the warming profile, until the infusion tubing is completely wrapped in the warming profile.
- Page 29 Operator’s Manual FT1800 KEEWELL • Place the ends of the warming profile into the holder to prevent the infusion tube contacting with the ground.
- Page 30 Operator’s Manual FT1800 KEEWELL • Press the key or the key to select the desired temperature. • Adjust the appropriate infusion rate. As soon as infusion is started, press the key start warming. • Resetting of temperature can only be performed in Standby mode.
- Page 31 Operator’s Manual FT1800 KEEWELL End of the warming profile for out flowing Holder for warming profile Head of the warming profile for in flowing Fig. 6: Illustration of the holder of warming profile...
- Page 32 Operator’s Manual FT1800 KEEWELL Shutting down the device • Press the key to enter 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 33: Maintenance
Operator’s Manual FT1800 KEEWELL 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. • Only disinfect the device with a disinfectant based on alcohol. -
Page 34: Periodic Inspections
Operator’s Manual FT1800 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 35 Operator’s Manual FT1800 KEEWELL 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. In this event the sign lights up, accompanied with acoustic signal. The heating is switched off automatically. The continuously decreasing of the temperature is observed.
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Page 36: Trouble Shooting
Operator’s Manual FT1800 KEEWELL TROUBLE SHOOTING Fault Possible Causes Remedy ⚫ Lack of / incorrect ⚫ Check socket/fuse, compare Nothing illuminates on power supply mains voltage with details on the panel ⚫ Mains connection cable rating plate or mains plug defective ⚫... - Page 37 Operator’s Manual FT1800 KEEWELL 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 exceeds 42℃ ⚫ Sensors defect ⚫ Call a service person ⚫...
- Page 38 Operator’s Manual FT1800 KEEWELL temperature information signal: ⚫ The input temperature ⚫ Lower the flow rate or preheat Flashing accompanied with of the fluid to be heated the fluid in another way acoustic alarm is too low or the flow rate is too high.
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Page 39: Manufacturer's Declaration
Operator’s Manual FT1800 KEEWELL MANUFACTURER’S DECLARATION The blood and infusion warmer FT1800 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 FT1800 comply with Directive of the European... -
Page 40: Emc Declaration
EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emissions The FT1800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT1800 should assure that it is used in such an environment. - Page 41 EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic immunity The FT1800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT1800 should assure that it is used in such an environment.
- Page 42 5 cycles interruptions, it is recommended EN 61000-4-11 70 % UT 70 % UT that the FT1800 be powered from an (30 % dip in UT ) (30 % dip in UT ) uninterruptible power supply or a for 25 cycles for 25 cycles battery.
- Page 43 EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The FT1800 is intended for use in the electromagnetic environment specified below. The customer or the user of the FT1800 should assure that it is used in such an environment.
- Page 44 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FT1800 is used exceeds the applicable RF compliance level above, the FT1800 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the FT1800.
- Page 45 Recommended separation distances between portable and mobile RF communications equipment and the FT1800 The FT1800 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FT1800 can help prevent electromagnetic interference...
- Page 46 Operator’s Manual FT1800 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 47: Symbols
Operator’s Manual FT1800 KEEWELL SYMBOLS The following symbols may appear in this manual, on the device, or on its accessories. Some of the symbols represent standards and compliances associated with its use. Caution: Consult accompanying documents CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. - Page 48 Operator’s Manual FT1800 KEEWELL Increasing temperature setting Decreasing temperature setting Standby / Operating Switch key between Celsius and Fahrenheit Over - temperature alarm Under - temperature alarm Sensor fault Warming profile is switched on Temperature setting Warming time Type BF applied part, Defibrillation- protection...
- Page 49 Operator’s Manual FT1800 KEEWELL Potential Equalization Conductor Side up Keep away from water Fragile...
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Page 50: Technical Data
Operator’s Manual FT1800 KEEWELL TECHNICAL DATA Model: FT1800 Power supply: a.c.100 - 240V/50-60 Hz Power input: 1.5A/ a.c.115 V 1.0A/ a.c.230V Fuse: 2×T2.5A/250V Type of protection against electric shock: Class I Degree of protection against electric shock: BF Applied part; Defibrillation-protected... - Page 51 Operator’s Manual FT1800 KEEWELL Operating mode: Continuous MDD Classification: IIb according to rule 9 Dimension control body: (W×D×H) 85×65×175mm Dimension control unit overall: (W×D×H) 160×111×185mm Net weight: 1.2kg Warming profile: length 1.4 m, for infusion tube 3.5-5mm(O.D.) length 1.4 m, for infusion tube 6-7mm(O.D.)
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Page 52: Operating And Storage Conditions
Operator’s Manual FT1800 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 53: Manufacturer Liability
Operator’s Manual FT1800 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 54: Warranty Conditions
Operator’s Manual FT1800 KEEWELL WARRANTY CONDITIONS The manufacturer guarantees that any material or structural defect occurring during the warranty period will be repaired free of charge. A claim under this warranty can only be made under the following conditions: •... - Page 55 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...