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Summary of Contents for DigiCare IP41 Series
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Infusion Pump IP41x Series Operator’s Manual Please read this Operation Manual carefully and follow Precautions for Use before using the IP41X Series Infusion Pump . Version 1.1 DIGICARE ANIMAL HEALTH...
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DIGICARE ANIMAL HEALTH Thank you for using the IP41x infusion pump from Digicare. All products manufactured by Digicare Biomedical Technology Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment.
This product is not intended for blood transfusions. 1.3 Product Features Series DIGICARE IP41x is a micro-continuous infusion pump. It ensures constant infusion speed and accurate dosing volume during long time infusion. This infusion pump is used for continuous and micro-volume infusion of liquid or liquid...
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Overview ⚫ Setting for automatic prompt of maintenance interval. ⚫ Modular installation design enables multi-channel pumps among pumps. Note: Drip sensor, Barcode scanner, WI-FI communication module, voice communication, nurse call and relay infusion function are optional. 2 / 63...
Precautions For Use 2 Precautions for Use In this manual, precautions are classified into warning and caution as follows: WARNING: A Warning alerts you to a potential serious outcome, adverse event or safety hazard. Failure to observe a warning may result in serious injury. CAUTION: A Caution alerts you to where special care is necessary for the safe and effective use of the product.
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Precautions For Use local regulations can be used on the infusion pump. Contact Digicare or your local distributor for more information. ⚫ Operations against the requirements, procedures, warnings and cautions provided in this manual may cause infusion failure, inadequate, overdosing, or other potential risks.
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Precautions For Use ⚫ Ensure that the infusion pump has been fixed tightly on the stand and the stand is stable. Prevent the pump from collision, dropping mechanical vibration or other impact of external forces to avoid damage on the pump. ⚫...
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Precautions For Use pump is normal. The Maximum infusion pressure at the end of the infusion tube generated by the pump may be up to 3500mmHg under the condition of occlusion when sensor failed. ⚫ The delay time between the onset of the alarm condition and the representation of the alarm is no longer than 150ms.
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Precautions For Use Symbols Authorized Representative in the European Community CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. Date of manufacture. Manufacturer Specifies serial number TYPE CF APPLIED PART Alternating current Direct current DISPOSAL: Do not dispose this product as unsorted municipal waste.
Product Specifications 3 Product Specifications Product name Infusion pump Series Model IP41x AC power supply: AC 100-240V,50/60 Hz, power consumption 45 VA External DC power supply: DC 12 V 1A Internal battery: lithium battery 11.1 V 1500 mAh Power supply Battery model: 154457 Time of battery continuous use: no less than 5 hours (for infusion at 25 mL/h rate with a new battery)
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Product Specifications If there is still alarm after mute alarm sound, it will alarm again in 2 minutes Event recording: can store and playback 2000 events maximum Sound volume: 11 levels are available Power supply switching: When AC/DC power supply is cut off, the infusion automatically switch to internal battery supply Barcode scanning: Input the patient information by barcode canning...
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Product Specifications systems in medical electrical equipment and medical electrical systems IEC60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety - Collateral standard: Electromagnetic compatibility requirements and tests 10 / 63...
Product Description 4 Product Description 4.1 Principle of Operation Series The IP41x infusion pump mainly consists of pump shell, display screen and operating system, monitoring system, alarm system, motor drive system, tubing peristaltic module, power supply system, drop sensor (optional), WI-FI communication module (optional), handle and pole clamp.
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Product Description 1 –Lighting lamp 2 – Depressor 3 – Anti-free-flow clamp 5 – Peristaltic pump plate 6 – Air bubble sensor 4–Anti-free-flow clamp button 7 –Pressure sensor 8 –Infusion tube slit 9 – Catch ⚫ Lighting lamp. To provide lighting in a dim environment, so as to install and check the infusion tube ⚫...
Insert the supplied AC power cord into the AC inlet on the right side of the infusion pump. Plug the cord into an AC power outlet with grounding terminal. ◼ To power the infusion pump with external DC power supply, contact Digicare or your local distributor. 16 / 63...
Operating Instructions 6 Operating Instructions 6.1 Display and keys ⚫ Display 1 – Alarm indicator 2 – TFT Touchscreen 3 – Home key 4 – ON/OFF key – OPEN key 1. The alarm indicator indicates alarms with three colors: red, yellow and green, respectively to the alarm high, medium and low priority alarms.
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Operating Instructions Occlusion pressure alarm level set: 2 Occlusion pressure real-time: a full set of 5 bars. The more bars displayed, the larger pressure it is. External power source. Displays when external AC/DC power source is connected. Screen lock symbol, consists of lock and unlock. Battery volume and charging states: a full set of 4 bars, the more bars displayed, the larger battery volume.
Operating Instructions ⚫ Direct Keys There are also 3 direct keys on the key panel: [HOME], [ON/OFF] and [OPEN] ◼ [HOME]: Main menu key. Before infusion, press [HOME] once to enter a setting menu, such as Infusion set, Local set, History and Interconnect set. To return to the infusion preparing interface, press [HOME] once again in any setting interface.
Operating Instructions WARNING: ⚫ After the power switch is turned on, confirm the loudspeaker, warning indicator is working all right, and check if the self-test is finished and no error messages appear. (Refer to Chapter 8 Troubleshooting.) ⚫ Ensure the displayed IV set brand corresponds with the using IV set brand. ⚫...
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Operating Instructions 2. Edit and Calibrate IV Set brand Press “Home” key twice to enter the Home screen. 2.1. Then press “System Set” and press “Maintenance”. 2.2. Press “Local Set”, enter password “1666”, click “Confirm” 2.3. Press “Consumable setup”. 2.4. 21 / 63...
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Operating Instructions Press “Calibrate”. 2.5. Press “Edit”. 2.6. Press “Producer”. Use the back “arrow” to erase the current Brand and 2.7. type the new IV set Brand and press “confirm”. Repeat same procedure to edit the new IV Model and Size. Size is the milliliters (ml) per drop specification.
Operating Instructions 6.4 IV set installation ⚫ Insert the needle into IV bottle vertically, and the liquid infuses into the drop chamber. ⚫ When the liquid level is at 1/3 of the drop chamber, open the roller clamp. ⚫ Infuse liquid into the tube to purge the air, and then close the roller clamp. ⚫...
Operating Instructions CAUTION: 3. To ensure the accuracy of drop detection, the drop sensor should be installed as far as possible close to the down liquid level. The liquid level is appropriate to be in the 1/3 of the drop chamber. 4.
Operating Instructions ⚫ Click [PURGE], then click [yes] on the pop-up interface, the infusion pump would purge quickly. Click [stop], the purge stops. ⚫ The green indicator flashes when purging. ⚫ Relationship between IV set specifications and purge rate, refer to the Table 6-1. Table 6-1 Relationship between IV set specifications and purge rate IV set specification(d/mL) Purge rate(mL/h)
Operating Instructions Table 6-2 Relationship between IV set specifications and range IV set specification (d/mL) Setting range (mL/h) 0.1-1200.0 Table 6-3 Relationship between rate range and the minimum increment Rate range(ml/h) Minimum increment(ml/h) 0.10 - 99.99 0.01 100 - 999.9 1000 - 1200 CAUTION: ⚫...
Operating Instructions ⚫ After entering the rate, if click [Cancel], it will return to original infusion interface without change; Click [Confirm], it will return to original infusion interface and operates at the new rate. CAUTION: ⚫ If no operation is performed in reference and setting rate interfaces for more than 10 seconds, it will return to infusion interface automatically.
Operating Instructions ⚫ Choose “Automatic Bolus”, during infusion; click [Bolus] to enter the bolus setting interface. Set any two of Bolus VTBI, Bolus rate and Bolus Time, click [Bolus Start] to enter the bolus interface, click [Bolus Stop] to stop the bolus. Bolus rates are different depending on the IV set specification as follows.
Operating Instructions 6.13 Turning the Power Off ⚫ Press the [ON/OFF] key, choose Power Off, Standby or Cancel. ⚫ Click [Power Off] to shut down. ⚫ Click [Standby] to enter standby interface, the standby time can be modified 29 / 63...
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Operating Instructions ⚫ Click [Cancel] to return to previous interface. 30 / 63...
Setting the Infusion Pump 7 Setting the Infusion Pump CAUTION: ⚫ After the pump is shutdown, all parameter settings will be automatically saved. ⚫ Parts of parameters will not be saved in force shutdown. 7.1 Infusion set Press [HOME] key to enter the setting interface, click [Infusion Set] to enter the detailed infusion setting interface.
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Setting the Infusion Pump ◼ Weight mode Under the Weight Mode, set the drug Info, Dose Rate, Weight and VTBI, the device will calculate the rate automatically, click [Confirm] to operate. ◼ Trapezia mode Under the Trapezia Mode, set the drug name, VTBI, rate, rise time and fall time, automatically calculate the rate, and then click [Confirm] to operate.
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Setting the Infusion Pump ◼ Sequence mode Under the Sequence mode, set the drug name, 10 sequence rate and time, click [Confirm] to operate in sequence. ◼ Drip mode Under the Drip mode, set the drug info, loading dose, loading time dose rate and weight, automatically calculate the rate, and then click [Confirm] to operate.
Setting the Infusion Pump ⚫ The drug library function could be applied to all working modes. The therapy data of the drug library is not edited by the manufacturer. 7.1.2 Occlusion Level ⚫ levels of occlusion are available (Factory setting is level 6). Table 7-1 Relations between occlusion level and pressure Occlusion Pressure...
Setting the Infusion Pump ⚫ There are three modes: Manual Bolus, Rapid quantitative Bolus and Automatic Bolus. Please refer to the chapter 6.9 for further instructions. 7.1.4 KVO Rate ⚫ KVO-rate could be adjusted from 0.1ml/h to 5ml/h (Step by 0.01ml/h), Default rate: 1ml/h.
Setting the Infusion Pump CAUTION: 8. If disconnected the drop sensor but the drip mode is open, the pump produces no drop sensor alarm. 7.1.8 Micro Mode Set 9. Open the Micro Mode, the maximum rate can be set under the mode. 7.1.9 Air bubble testing level ⚫...
Setting the Infusion Pump 7.2 Local Set Local Set 7.2.1 Volume Setting ⚫ volume levels are available (The factory setting is level 5). Volume password is 1234. CAUTION: ⚫ Do not set the alarm volume lower than the ambient noise to ensure the alarm can be heard and recognized correctly.
Setting the Infusion Pump ⚫ There are seven different color options for UI type. ⚫ The brightness can be adjusted in [Normal Bright]. ⚫ All the parameters of the night mode can be adjusted here. CAUTION: ⚫ Under the night mode, setting range of start time is 17:00-09:00, finish time range is the same as start time range.
Setting the Infusion Pump CAUTION: ⚫ The pump can communicate with workstation, and the workstation can manage the alarm and implement relay function between pumps. ⚫ The setting of [Local RS485] and [Station RS485] must be done by the manufacturer’s representatives. Please contact manufacturer or local dealer for further information.
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Setting the Infusion Pump ⚫ Click [Auto Lock] to set up the screen auto lock function. This function can be set as: OFF, 15s, 30s, 1min, 2min, 5min, 10min, 30min. The default value is OFF, which means the screen auto lock function is disable. 40 / 63...
Setting the Infusion Pump 7.2.5 Collection Set ⚫ [Mode Collection]: Choose the frequently used infusion mode from the [Infusion mode] option. Once the frequently used infusion modes are chosen, the unnecessary modes will not appear in the list of 7.1.1 [Infusion mode] option. The default setting is “all the four infusion modes are chosen”.
Setting the Infusion Pump 7.2.7 Pressure Unit ⚫ Choose the measurement unit for the pressure. The optional units are: mmHg, kPa, bar and PSI. The default setting is mmHg. 7.2.8 Date & Time set ⚫ Set the date, time, and their format. 7.2.9 Maintenance ⚫...
Setting the Infusion Pump 7.3 History The history records are as Table 7-2. Table 7-2 History records Event Record Parameters Start up Occurred time Shutdown Occurred time Standby Occurred time, standby set time Start Occurred time, rate, VTBI Bolus Occurred time, Bolus rate, Bolus way Bolus stop Occurred time, Bolus rate, Bolus accumulated volume Stop...
Setting the Infusion Pump 7.4 Patient File ⚫ Click [Patient File] to enter the patient file page. The [Department], [Room No.], [Bed No.] and [Patient Data] can be set up. ⚫ Click [Patient Data] option to enter patient data setting page. Choose [New] to build a new patient data and the previous patient data will be cleared automatically.
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Setting the Infusion Pump number of active indicators. For details, see Table 7-3. Table 7-3 when battery works, the [Battery capacity] diagram state [Battery capacity] state The remaining capacity*1) Four bars light Operation will be possible for 300 minutes. Three bars light Operation will be possible for 210 minutes.
Setting the Infusion Pump 7.6 Connecting to the Infusion Central Monitoring System(optional) Infusion pumps can be connected to the Infusion Central Monitoring System, which can obtain working states of pumps remotely. CAUTION: ⚫ Infusion pump cannot be operated through the Infusion Central Monitoring System. 7.7 Nurse call (optional) After infusion pump is connected to the central station, patient can press nurse pager in bed, and then the central station in nurse station would give out sound tip and...
Troubleshooting 8 Troubleshooting 8.1 Alarm The infusion pump provides users with a variety of status information about itself and its injection process. If any abnormality is detected, the infusion pump sounds an alarm and notes users in the form of sound, light, and character. All the alarms on this pump are the technical type alarm.
Troubleshooting 8.2 Faults and Troubleshooting Table 8-2 Alarm symptom, alarm level, fault cause, and troubleshooting Alarm Symptoms Alarm level Causes Troubleshooting No external AC/DC power Immediately connect the AC No Power Supply Low-level supply is connected. power supply or the external DC power supply.
Troubleshooting Alarm Symptoms Alarm level Causes Troubleshooting Drop Error Low-level The drip rate is detected to Press [Cancel] to remove be incorrect at the drip kettle alarm check during the infusion. installation drop sensor. No drop sensor Mid-level The drop sensor detection Install the drop sensor or function is turned on, but turn...
Maintenance 9 Maintenance 9.1 Cleaning, Disinfecting ⚫ Before cleaning the pump, be sure to turn off the power and disconnect the AC or DC power cables. ⚫ If there is dirt on the pump, wipe it with wet soft cloth dampened with cold or lukewarm water.
Maintenance representatives for replacement in time. ⚫ If you connect the infusion pump to the AC/DC power and there is no indication of powering on, contact manufacturer or manufacturer’s representative for maintenance in time. 9.2.3 Checking the infusion rate ⚫ Check the infusion flow once a year by the graduate and timer.
Maintenance ◼ If the time from the start of the infusing to end of operation is less than 1 hour, the battery has reached its service life. Replace the battery. You are advised to contact manufacturer or manufacturer’s representative to replace the battery. ⚫...
Maintenance failure. The manufacturer and the distributor shall not be responsible for any infusion pump that has been disassembled, modified or used for any purpose other than that for which it is intended. ⚫ If the infusion pump is dropped or subjected to impact, remove it from service even if it doesn’t appear damaged externally.
Infusion Accuracy Characteristics 10 Infusion Accuracy Characteristics The following test is performed in accordance with the IEC60601-2-24:2012 standard. It is used to observe the infusion accuracy and the occlusion response. (For detailed test conditions, see the IEC60601-2-24:2012 standard.) CAUTION: ⚫ The infusion accuracy and the occlusion response may be affected by the use conditions including the pressure, temperature, humidity, IV set, and infusion tube.
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Infusion Accuracy Characteristics ◼ Table 10-1 Accuracy test result Administration set (IV Accuracy(%) Remarks set) Brand +4.79 Minimum rate 1ml/h, normal condition -0.71 Intermediate rate 25ml/h, normal condition Intermediate rate 25ml/h, with +13.3kpa +0.91 backpressure B.Braun Intermediate rate 25ml/h, with -13.3kpa 20d/mL +0.79 backpressure...
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Infusion Accuracy Characteristics ◼ Table 10-2 Accuracy test result Start-up curves of Hospira 1mL/h Start-up curves of Hospira 25mL/h Trumpet curve of Hospira 25mL/h Trumpet curve of Hospira 1mL/h Start-up curves of B.Braun 25mL/h Start-up curves of B.Braun 1mL/h Trumpet curve of B.Braun 25mL/h Trumpet curve of B.Braun 1mL/h 56 / 63...
Infusion Accuracy Characteristics 10.2 Occlusion Characteristics The occlusion characteristics are reflected by the longest delay time to start an alarm. The following test method is accordance with the method mentioned in chapter 201.12.4.4.104 of the standard IEC 60601-2-24:2012 (Please check above chapter for further details.).
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Appendix A Appendix A Electro Magnetic Compatibility (EMC) The IP41x Series Infusion Pump conforms to EMC standard EN 60601-1-2. Guidance and manufacturer’s declaration – electromagnetic emissions The IP41x Series Infusion Pump should be used under the regulation electromagnet environment. The user should operate the IP41x Series Infusion Pump under following electromagnet environment.
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Appendix A Guidance and manufacturer’s declaration – electromagnetic immunity Series The [IP41x ] is intended for use in the electromagnetic environment specified below. The Series customer or the user of the [IP41x ] should assure that it is used in such an environment. IMMUNITY test IEC60601test level Compliance level...
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Appendix A Power 3 A/m 3 A/m Power frequency magnetic frequency fields should be at levels magnetic fields characteristic of a typical (50/60Hz) location typical IEC 61000-4-8 commercial hospital environment NOTE: U is the AC mains voltage prior to application of the test level. 60 / 63...
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Appendix A Guidance and manufacturer’s declaration – electromagnetic immunity Series The [IP41x ] is intended for use in the electromagnetic environment specified below. The Series customer or the user of the [IP41x ] should assure that it is used in such an environment. Immunity IEC 60601 Compliance...
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Appendix A Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. Series If the measured field strength in the location in which the [IP41x ] is used exceeds the...
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Appendix A Recommended separation distances between portable and mobile RF communications equipment Series and the [IP41X Series The [IP41X ] is intended for use in an electromagnetic environment in which radiated RF Series disturbances are controlled. The customer or the user of the [IP41X ] can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile Series...
Appendix B Appendix B The Default Factory Settings This chapter lists some default factory settings of infusion pump. Users can not modify the default factory settings, but if necessary, they can recover the infusion pump to the default factory settings state. Parameters Parameters setting The default factory setting...
Appendix D Appendix D Difference Between IP41X Series Model IP41X IP41XT IP41XA IP41XC Difference Infusion Mode Rate Rate Rate Rate Time Time Time Time Weight Weight Weight Weight Sequence Sequence Sequence Sequence Drip Drip Drip Drip Relay Relay Relay Relay Trapezia Trapezia Loading...
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Appendix D Air Bubble 7 levels 7 levels Level adjustable adjustable adjustable adjustable (25µl-800µl) (25µl-800µl) Drug Library Not support Not support Support Support (Drug (Drug selection in selection in any modes) any modes) IV Set Brand Not support Not support Not support Support Identity...
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