Summary of Contents for SK Medical SK-600i
- Page 1 SK-600Ⅰ Ⅰ Ⅰ Ⅰ (This Operator’s Manual is also applicable for SK-600Ⅰ Ⅰ Ⅰ Ⅰ B infusion Pump) Infusion Pump Operator’s Manual...
- Page 3 © 2011-2012 Shenzhen Shenke Medical Instrument Technical Development Co., Ltd. All rights reserved. For this Operator’s Manual, the issue date is April 2012.
- Page 4 Intellectual Property Statement SHENZHEN SHENKE MEDICAL INSTRUMENT TECHNICAL DEVELOPMENT CO., LTD (hereinafter called SK Medical) owns the intellectual property rights to this SK product and this manual. This manual may refer to information protected by copyright or patents and does not convey any license under the patent rights or copyright of SK Medical, or of others.
- Page 5 SK Medical reserves the rights to modify the Operator’s Manual without further notice. The modified parts will be present in the new edition of Operator’s Manual. SK Medical is not responsible for any software and devices provided by non SK Medical and distributors.
- Page 6 SK Medical or repairs by people other than SK Medical authorized personnel.
- Page 7 Company Contact Manufacturer: Shenzhen Shenke Medical Instrument Technical Development Co., Ltd http://www.skmedica.com E-mail Address: Service Hotline: +86 400 628 8806 Tel: +86 755 82402696 Fax: +86 755 82438567 Shanghai International Holding Corp. GmbH EC-Representative: (Europe) Eiffestrasse 80, 20537 Hamburg， ， ， ， Germany Address: +49-40-2513175 Tel:...
- Page 8 Preface Manual Purpose This Operator’s Manual describes the product’s application, function and operation in details. Please read this Operator’s Manual carefully and understand the content before use to ensure the proper usage and guarantee the safety of the patient and the user.
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Page 9: Table Of Contents
Contents 1 Safety ........................1-1 1.1 Safety Information ....................1-1 1.1.1 Dangers ....................1-1 1.1.2 Warnings ....................1-2 1.1.3 Cautions ....................1-4 1.1.4 Notes .......................1-5 1.2 Equipment Symbols ....................1-6 2 The Basics ......................2-1 2.1 Product Introduction ....................2-1 2.1.1 Application Scope ..................2-1 2.1.2 Contraindications ..................2-1 2.1.3 Product Structure, Composition and Performance .........2-1 2.2 Appearance ......................2-3 2.2.1 Front Panel ....................2-3 2.2.2 Back Panel ....................2-5... - Page 10 4.2 Operation Steps ....................4-2 4.2.1 Start Infusion Pump .................4-2 4.2.2 Install the Infusion Tube ................4-3 4.2.3 Setting Infusion Parameters ..............4-4 4.2.4 Clearing Accumulated Volume ..............4-4 4.2.5 Starting Infusion ..................4-5 4.2.6 Infusion Over ...................4-5 4.2.7 Shutdown ....................4-5 5 Function and Interface ..................5-1 5.1 System Function Setting ..................5-1 5.1.1 Setting Flow Rate ..................5-1 5.1.2 Setting Volume Limit ................5-1...
- Page 11 C Alarm information ....................C-1 C.1 Alarm information ....................C-1 C.2 Prompt Message ....................C-4 D Symbols and Terminology ................. D-1 D.1 Units ........................D-1 D.2 Terminology ......................D-2...
- Page 12 FOR YOUR NOTES...
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Page 13: Safety
Safety 1.1 Safety Information The safety statements presented in this chapter refer to the basic safety information that the operator shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the followings, or specific to the operations. -
Page 14: Warnings
1.1.2 Warnings WARNING This infusion pump is used for clinic infusion, do not for intestinal or gastric nutritional feeding solution. It can only be used by professional clinicians, medical electrical experts, or well- trained nurses on specific occasions. Infusion pump and its accessories must be inspected before use to guarantee its normal and safe operation. - Page 15 Disposable accessories must be disposed after use in accordance with the relavant regulations of the hospital. This infusion pump belongs to Class II (type of electric shock protection), the supplied Type I power cord PE earth terminal should not be used as ground protection and functional earthing.
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Page 16: Cautions
1.1.3 Cautions CAUTION Please use the accessories specified in this Operator’s Manual to gurantee the safety of the patient. Cables must be connected carefully to reduce the possibility of the patient getting intertwined or choked. Disposable accessories can only be used once. Repeated use may lead to declined performance or cross-infection. -
Page 17: Notes
If the surface tention, proportion and viscosity of the infusion solution is different from saline (for example, a kind of solusion mixed with surface activiting agent), the infusion accuracy may be different from the accuracy listed in the specifications table. When the infusion rate is high (≥... -
Page 18: Equipment Symbols
1.2 Equipment Symbols Note! Please refer to the Class II Equipment Operator’s Manual IP21 Type BF applied parts Splash-proof Alternating Current Power Direct Current Power Supply Supply (AC) (DC) Batch No. Serial No. Date of Production Manufacturer Pollution-Free Treatment Wireless transceiver Upward or Add Value Downward or Reduce Value Confirm... -
Page 19: The Basics
The Basics 2.1 Product Introduction 2.1.1 Application Scope This infusion pump is used in wards, operation rooms, and observation rooms for accurate and continuous infusion to patients. Do not for intestinal or gastric nutritional feeding solution. Any institutes or units, such as hospital outpatient, emergency rooms, wards, operation rooms, observation rooms, clinics, nursing home, etc., capable enough to provide health care, is expected to use this infusion pump. - Page 20 Pump Device: the power source of infusion，employs step motor to drive the pump tablets continuously extruding upon infusion tube to materialize infusion. Detection Device: the device mainly includes all kinds of sensors, like air bubble sensor (detect air bubble inside the infusion tubes), pressure sensor (detect the pressure inside the infusion tube), etc.
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Page 21: Appearance
2.2 Appearance 2.2.1 Front Panel 1.Running indicator light The light is on and flashes during infusion when the infusion tube was properly installed. - Page 22 2.SET key To set flow rate, volume limit, and Bed No. 3.STOP / SILENCE key In running status, press this key to stop infusion. When the alarm is on, press this key to silence the alarm (except low battery alarm). In value inputting status, press this key to stop saving the value newly set and quit.
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Page 23: Back Panel
2.2.2 Back Panel Vents Power tab Power socket Fixing Clamp Drop sensor socket (drop sensor is a selective purchasing accessory) Product label... -
Page 24: Screen Displaying
2.3 Screen Displaying This infusion pump is built with LCD screen. The displayed information contains four major parts: AC Power Information Displaying AC Power and battery icons Functional Modes Displaying Current functional modes Alarm information Displaying alarm information, e.g. air bubble, occlusion, empty, over. Parameter setting Displaying Parameter under setting or working parameters 2.4 Battery... -
Page 25: Battery Guidelines
WARNING Keep the battery out of the reach of children. Use only the battery specified by the manufacturer. NOTE When the battery capacity is 0 and in low battery condition, an alarm will be triggered within a few seconds to remind the users of low battery. Shortly after low battery alarm, the pump shall trigger a serious low battery alarm, the indicator light shall flash and the pump will give a rapid and short alarming sound. -
Page 26: Battery Maintenance
WARNING Using the battery provided by the manufacturer. Please replace the battery once the battery is damaged or leaks Damaged battery shall not be used The used battery shall be returned to the distributor or manufacturer, or be disposed according to applicable laws. 2.4.3 Battery Maintenance 2.4.3.1 Conditioning a Battery Optimize the battery when it is used for the first time. -
Page 27: Checking A Battery
2.4.3.2 Checking a Battery Regular check for the battery is needed due to the reason that the battery function will decrease during usage. Please follow the steps below when checking battery function Connect the pump to the AC power, charging continuously for 8 to 14 hours. Disconnect the AC power supply and let the machine work on battery until it is turned off due to battery exhausting. - Page 28 FOR YOUR NOTES 2-10...
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Page 29: Installation And Maintenance
Installation and Maintenance 3.1 Installation WARNING The software copyright of this infusion pump belongs to our company. Any infringement act such as falsification, reproduction or exchanging by any means or in any form by any organization or individual is not allowed without permission. -
Page 30: Environmental Requirements
3.1.2 Environmental Requirements The service environment of this infusion pump must meet the requirements in A.2 Product Specifications. The service environment of this infusion pump should also be appropriately protected from noise, vibration, dust, or corrosive, inflammable or explosive, Substances. There should be 2 inch (5cm) interspace around the infusion pump to make sure the air moves freely. -
Page 31: Fix Infusion Pump
3.1.4 Fix Infusion Pump [Figure 3-1] Direction for fixing infusion pump as shown in Figure 3-1: Steel tube of infusion pump stand Screw of clamp [Figure 3-2] [Figure 3-3]... -
Page 32: Install Power Cord
Steps to install infusion pump to infusion pump stand: 1. As shown in Figure 3-2, for convenience, counter-clockwise twist the clamp knob and make enough room for the installation of the pump on the stand. 2. As shown in Figure 3-3, place the stand at a position corresponding to the the clamp, and then twist the clamp knob clockwise till the infusion pump installed well on the stand. - Page 33 [Figure 3-4] [Figure 3-5] 1. Firmly insert the power cord of Drop Sensor to the connecting port on the rear panel, and make sure the volume of the liquid to be filtered less than 1/3 that of the liquid filter at meantime. 2.
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Page 34: Maintenance
3.2 Maintenance WARNING The hospital or medical establishment using this infusion pump must set up a complete maintenance plan. Otherwise, it may cause device failure or some unexpected consequence, and even threaten the personal safety. All the safety inspection or the maintenance work which involves the disassembling the device must be proceeded by the professional maintenance personnel. - Page 35 Our company will not take any responsibility for the effectiveness of the infection control with the following chemicals or methods. Please contact the infection prevention department of the hospital or epidemic experts for the method of infection control. Please keep your devices and accessories away from the dust, and comply with the following provisions to prevent the device damage: Please dilute the cleanser and disinfectant in accordance with the manufacturer’s indication, or with their concentration as low as possible.
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Page 36: Preventive Maintenance
When cleaning the device: Turn off the power, and disconnect the power cord. Wipe the case with soft cotton balls adsorbing the cleanser. Wipe the surface of the device with soft cloth adsorbing 75% of alcohol. Keep the device in the cool and ventilated environment to dry up. The above steps are for reference only. -
Page 37: Operation Guide
Operation Guide 4.1 Operation Flow Chart Fix the infusion pump on the stable infusion Fix the infusion pump tube stand; Start the infusion pump Press the key Fix the infusion tube to the groove bottom of the pump straightly, and check if there is any Install infusion tube leakage after well installation of the infusion tube;... -
Page 38: Operation Steps
4.2 Operation Steps NOTE Part of this section covers the function of Drop Sensor. If the user needs to use this function, it is necessary to choose Drop Sensor as accessory to the infusion pump. For more details, please consult the distributor that sells the product to you or the manufacturer. -
Page 39: Install The Infusion Tube
4.2.2 Install the Infusion Tube (1) pull out the door lock as the arrowhead’s. (2) Pull straight the infusion tube. Install the two ports of infusion tube to the bottoms of the infusion groove. (3) Place the infusion tube to the bottom (4) Pull down the handle after of the pump’s groove straightly and installation. -
Page 40: Setting Infusion Parameters
WARNING Pull down the handle after installation of infusion tube properly when the pump is on. When green indicator light is on, it means the infusion tube is proper installation. Otherwise, infusion tube need reinstallation. When use the same infusion tube, change the part of pipe installed in groove of machine every 4 hours. -
Page 41: Starting Infusion
NOTE The accumulated volume can cleared only when the infusion pump is in stop status. 4.2.5 Starting Infusion After setting all the parameters and proper installation of the infusion tube, press the key, the motor begins to run, and the pump starts infusing. The indicator light is flashing when the machine is working. - Page 42 NOTE The battery ca not be recharged when the machine is turned off Rate and the other parameters shall return to default values after machine is turned off...
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Page 43: Function And Interface
Function and Interface 5.1 System Function Setting 5.1.1 Setting Flow Rate As shown in Figure 5-1, turn on the infusion pump to enter the infusion mode interface. Press key in “Stop” status to enter the mode of parameters settings. Press key to select the flow rate, volume limit and bed No. -
Page 44: Setting Bed No
“1” first, and then press key or key to a increase or reduce 100, 10, or 1 from the initial value. Press to save the value newly setting. [Figure 5-2] NOTE Volume Limit: 1~9999 ml/h 5.1.3 Setting Bed No. As shown in [Figure 5-3], turn on the enteral feeding pump and press key in “Stop”... -
Page 45: Starting Bolus Function
5.2 Starting Bolus Function During the infusion, if you need to accelerate the infusion when the current flow rate is under the bolus rate (600ml/h), please keep pressing key to increase the flow rate to 600ml/h, and release the key to return to the original flow rate. NOTE The bolus function should be used under normal infusion. -
Page 46: Changing Brand Of Infusion Tube
NOTE The pressure factor ranges from 40 to 150. Please save the factor if it is within the normal limits, and exit from the interface; if not, there will be voice prompts and the calibrated parameter is just the value saved last time. -
Page 47: Calibrate The Accuracy
If you need to change the brand of the infusion tube or set its corresponding parameters, please take the following steps: Press key and key (which stands for the increment of 100) at the same time as is shown in [Figure 5-6]. The LCD will display A on the top right corner. Press key and key (which stands for the increment of 10) at the same... - Page 48 When there is error during infusion or change to a new infusion tube, please recalibrate the accuracy of the pump as follows: Step 1: Turn on the infusion pump, set the flow rate at 150ml/h and preset volume at 20ml. Start infusion after installation of new brand of feeding pipe properly. Use the measuring cup to measure the liquid volume flowed from the infusion tube.
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Page 49: Setting Occlusion Level
5.4.3 Setting Occlusion Level [Figure 5-10] As shown in Figure 5-10, there are 3 lines of value displayed on the LCD after pressing the key and the key simultaneously. The first-line value, standing for occlusion level, flashes and is adjustable on the default status. Increase or decrease the parameter value by pressing the key or the key NOTE... -
Page 50: Drop Rate Function (Optional)
[Figure 5-11] NOTE The higher the filter level, the larger capacity the air bubble filtered. 5.5 Drop Rate Function (Optional) NOTE The Drop Rate function in this section needs suport of software. For more details, please consult the distributor that sells the product to you or the manufacturer. -
Page 51: Setting Drop Rate For Infusion Tube
[Figure 5-12] [Figure 5-13] 5.5.2 Setting Drop Rate for Infusion Tube When different kinds of infusion tubes are used, it is necessary to refer to the parameters on the package of infusion tube, because of different drop rate parameters for different infusion tubes. As shown in Figure 5-14, on the display of starting infusion pump, select the infusion tube (i.e.: A brand infusion tube) that the system needs. -
Page 52: Convert The Drop Rate Unit
[Figure 5-14] NOTE The setting range for infusion tube: 1~100. 5.5.3 Convert the Drop Rate Unit As shown in Figure 5-15, under the infusion stop status, press the key to enter into the interface of infusion parameters setting. Then press the key and the 1-increment key simultaneously, the flow rate will convert between unit /min... -
Page 53: Alarms
Alarms 6.1 Overview Alarm is a warning indication given by infusion pump to alert medical care personnel through sound, light, information etc. Alarm occurs in case of completed infusion, accidental circumstance (machine abnormal, installation error of infusion tube) or machine malfunction that result in abnormal infusion. WARNING There is a potential hazard for the same or similar devices to use different preset alarm in any single area. -
Page 54: Alarm Countermeasures
Battery exhausted Communication error: Err1 Operation error: Err2 Drop rate error: Err3 Handle opened: Err4 6.3 Alarm Countermeasures WARNING Please check the condition of the patients when an alarm occurs. When the infusion pump gives alarms, please take the following steps and measures: Check the condition of the patient. -
Page 55: A Product Specification
Product Specification A.1 Safety Specification Parameter Standard SFDA Classification Class II Type of Shock Protection Class II, including inner power supply device Type BF, except quiver discharge effect Degree of Shock Protection application part. Classification of Waterproof IP21 Operating Mode Continuous operation Degree of Mobility Portable device... -
Page 56: Hardware Specification
The battery shall charge automatically when the pump is connected to the AC Charging Time power and in power on situation. It takes 8-14 hours for the battery to get fully charged. A.4 Hardware Specification Parameter Standard Complete Appliance 120 mm×140 Size mm×195mm(Length×Width×Height) Weight... - Page 57 value and unit, volume limit, volume limit value and unit, accumulated volume, accumulated volume value and unit, Over, occlusion, air bubbles, bed No., etc. Status indication Stop, infusion, bolus, KVO Alarm function Air bubble, Over, occlusion, no AC power, low battery, batter exhausted, communication error (Err1 displayed), operation error (Err2 displayed), drop rate error (Err3 displayed),...
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Page 58: Pressures That Trigger A Occlusion Alarm, Maximum Alarm Delays, And Permissible Maximum Volumes Per Infusion
A.6 Pressures that trigger a occlusion alarm, maximum alarm delays, and permissible maximum volumes per infusion Actually measured Reference High dose Flow rate value of pressure Alarm time occlusion value volume (ml/h) intensity (Min) (Kpa) (ml) (Kpa) 40.80±10 00:03:44 0.29 100ml 43.47±10 00:00:10... -
Page 59: Infusion Accuracy Table
A.7 Infusion accuracy table The accuracy chart is as follows, indicating the infusion change from the beginning of infusion to steady infusion. A.7.1 Accuracy Curve It is based on the data from a two hours’ observation cycle. Sampling rate: 25ml/h Sampling intervals: △... - Page 60 A.7.2 Horn-shaped curve The deviation of infusion rate in short term (p △ Sampling rate: 25ml/h Sampling intervals: △ t = 0.5 minutes Observation window duration: p △ t =2, 5, 11, 19, 31minutes Max. deviation in Provisions Duration: EPmax (%) Min.
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Page 61: B Emc Guidance And Manufacturer's Declaration
EMC GUIDANCE AND MANUFACTURER’S DECLARATION This infusion pump meets the EMC standard EN 60601-1-2. Note Using the acessories, sensors and cables beyond the specified range may increase the ● electromagnetic emission of infusion pump or reduce the electromagnetic immunity. The infusion pump must not be closed or stacked with other equipments. When infusion ●... - Page 62 Guidance and Statement of Electromagnetic Immunity The infusion pump should be used under stipulated electromagnetic environment. Customer or user shall ensure using infusion pump under the following stipulated electromagnetic environment. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guidance Electrostatic ±6 kV contact discharge ±6 kV contact discharge...
- Page 63 Guidance and Statement of Electromagnetic Immunity The infusion pump should be used under stipulated electromagnetic environment. Customer or user shall ensure using infusion pump under the following stipulated electromagnetic environment. IEC 60601 Test Compliance Immunity Test Level Level Electromagnetic Environment - guidance Conduction 3 Vrms Portable and mobile RF communications...
- Page 64 Recommended Distance Between Infusion Pump and Portable/Mobile RF Communication Equipment The infusion pump can be used in the electromagnetic environment where RF interference can be controlled. In order to avoid electromagnetic interference, the customer or user should ensure that the infusion pump and portable/mobile RF communications equipment maintain the minimum recommended distance .The following recommended distance is calculated according to the maximum output power of communication equipment.
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Page 65: C Alarm Information
Alarm information C.1 Alarm information Note: Column A means it can be totally eliminated; Column B means it can be eliminated to acousto-optic; Column L means the alarm level. Alarm Display Causes Solutions Air bubble High Air bubble in the Press to stop infusion tube. - Page 66 Alarm Display Causes Solutions Malfunction with the Contact manufacturer. sensor. No AC Low The power cord does Check whether the power not connect to the ac power cord has been power supply. inserted or well inserted. There is a problem Contact manufacturer.
- Page 67 Alarm Display Causes Solutions Communica High Internal data Press to stop tion error communication error. (Err1) infusion and eliminate alarm. Press again to restart infusion. If this alarm appears again, please contact the manufacturer for repair. Hardware fault. Press for direct shutdown.
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Page 68: Prompt Message
Alarm Display Causes Solutions Drop rate High Setting error of drop Set the correct drop rate error (Err3) rate parameter. parameters. (drop rate sensor is required) Accuracy is not Calibrate the accuracy calibrated. of the infusion tube again. There is droplet on the Shake off the droplet on funnel tube wall after the tube wall. -
Page 69: D Symbols And Terminology
Symbols and Terminology D.1 Units Abbreviation Meaning Minute Hour Hertz Milligrams Gram Kilogram Kilopascal Milliliter... -
Page 70: Terminology
D.2 Terminology Abbreviation Meaning Magnatic resonance imaging Altenating current Direct current Electromagnetic compatibility Keep vein open Error International Electrotechnical Commission International organization for Standardization light emitting diode Central processing unit Random access memory Read-only memory... - Page 72 046-003545-00-1000-3.0...
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