Hedy HealFusion User Manual

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HealFusion

Infusion Pump User Manual

(i7, ip-3)

HEDY Medical Device Co. Ltd.

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Page 1 HealFusion Infusion Pump User Manual (i7, ip-3) HEDY Medical Device Co. Ltd.
Page 2 Product Information Congratulations on your purchase of HealFusion Infusion Pump. Before using this product, please read this manual carefully for proper use of the product. Please keep this manual after reading so that you can access at any time when needed.
Page 3: Table Of Contents
Contents Chapter 1 Safety Precaution ............1-1 Safety Signs ................1-1 Safety Information ..............1-2 Electric Safety Preventive Measurements ........1-4 Contraindications ................ 1-5 EMC ................... 1-5 Environment Safety Preventive Measurements ......1-5 Chapter 2 Brief Introduction ............2-1 Brief Introduction of the User Manual ........2-1 Brief Introduction of the Pump ...........
Page 4 3.3.5 Trapezia Mode ................3-12 3.3.6 Intermittent Mode ..............3-14 3.3.7 Loading Dose Mode ..............3-15 3.3.8 Sequence Mode ................. 3-17 Relay Mode ................3-18 Settings ..................3-18 3.5.1 VTBI Finish Setting ..............3-20 3.5.2 Manual Bolus setting ..............3-21 3.5.3 Push Vol.
Page 5 Service ..................3-36 Chapter 4 Technical Data ...............4-1 Infusion Accuracy ................ 4-1 KVO Mode ................... 4-2 Blocking Threshold..............4-3 Chapter 5 Alarm and Tips ...............5-1 Alarm Function ................5-1 Alarm Priority ................5-1 5.2.1 High-level Alarm ................ 5-2 5.2.2 Intermediate-level Alarm ............5-4 5.2.3 Low-level Alarm .................
Page 6 Preface Statement HEDY Medical Device Co., Ltd. (hereinafter referred to as the manufacturer) has the copyright of this non-publication manual. This manual is for reference only while operating, maintaining and repairing the manufacturer’s products. Other persons have no right to disclose the content of this manual to any other persons.
Page 7  The machine is used according to the conditions and requirements described in this manual. User Notice  To ensure operation safety and long-term stable performance of the system, it’s strongly recommended reading this manual to get a full knowledge on the function, operation and maintenance before operating the system.
Page 8  The manufacturer takes no responsibility for any damage caused by other system or unauthorized connection to other systems.  The manufacturer takes no responsibility for any loss, damage or harm caused by delayed service request.  Please report to the manufacturer after-sale service department if the system has any malfunction.
Page 9: Chapter 1 Safety Precaution
Chapter 1 Safety Precaution 1.1 Safety Signs The following messages can be read throughout this manual, they are supposed to be paid special attention to. A WARNING label applies to information that may cause severe personal injury, death or actual property loss WARNING! if neglected.
Page 10: Safety Information
Serial number Manufacture date Manufacture information European community representative General warning sign Flow direction arrow Non-ionizing radiation IPX3 Waterproofing grade 1.2 Safety Information Safety of the operator or the examinee, and reliability of the system are generally considered during designing and manufacturing. However the following safety preventive instructions should be followed.
Page 11 Avoid operation or storage in the following environments:  Sharp temperature variance.  Rather high humidity, poor ventilation.  Water vapor exposure, do not operate the system with wet hands.  Near heat-emitting systems.  Direct solar irradiation.  Violent shakes or vibration. ...
Page 12: Electric Safety Preventive Measurements
 If the pump fall or bump, it must be inspected and tested by service personnel.  After selecting the location to place the equipment, before installing this system, please make sure the power supply is normal. The emergency measure and corrective action during use ...
Page 13: Contraindications
To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth. WARNING!  Do not open the enclosure without permission. Do not change any other parts of the pump without permission.  In case of any equipment failure, cut off the power supply immediately and contact the manufacturer or its authorized agent.
Page 14  Equipment and accessories probably cannot be normal used at the end of life, ensure to replace the equipment or accessories timely to decrease the risk to the minimum. The battery inside the device is not replaceable.  Harmful substances and the content in the product: Table 1-2 Harmful Material and Its Content Hazardous Substance Component...
Page 15: Chapter 2 Brief Introduction
Chapter 2 Brief Introduction 2.1 Brief Introduction of the User Manual  This User manual introduced the HealFusion Infusion Pump. It applies enough information for the user to operate and storage the pump. Please read it carefully before using. ...
Page 16: Brief Introduction Of The Pump
 Congratulations on your purchase of HealFusion Infusion Pump. This system is a high quality system which is stable and convenient to operate. It is suitable for all qualified doctors, this pump consists of the following modes: ...
Page 17: Device Features And Intended Use
 Mode of operation: Continuous; 2.3 Device Features and Intended Use  Intended use: working with the infusion set. The pump is suitable for the hospital operating room, ICU, outpatient and general wards and other places, which is used to control the flow of liquid infused into the patient. The injection site support for intravenous.
Page 18 Figure 2-1 Pump Closed Figure 2-2 Pump Open...
Page 19 Figure 2-3 Rear View Table 2-1 Equipment Parts Description Table Num. Symbol Description Connect button Fixed stacked Infusion pump and syringe pump inch color Display menus and submenus, can be operated display by touching ALARM indicator indicates the alarm status, Indicator POWER indicator indicates the power status ON/OFF...
Page 20 Door fixed shaft Fixed the door Door sensor Detect the door’s state Infusion tube slot Fixed the infusion tube power connector(12(a)), RS232 Back interface Connector(12(b))  SIP/SOP function 12(b) is RS232 Connector, it provides: External DC voltage input function. RS232 Connector: RS232 interface can be used with a two-way communication, please ask our Customer Service Department to obtain an interface protocol if necessary, RS232 communication cable need to use shielded cable.
Page 21 Figure 2-4 Operating Panel Diagram Table 2-2 Description Table Symbol Name Description ON/OFF button Press to turn pump RUN/STOP button Press to start/stop infusion. Press to silence alarm for two minutes (configurable). Or cancel MUTE/BACK button the operation and return to the previous menu.
Page 22 Flashing red: high level alarm. ALARM indicator Yellow: low level alarm. Flashing green: battery charged. BATTERY indicator Steady green: battery full. Steady red: battery error. Lit up when the pump is AC POWER indicator connected to an AC power supply. Note: BOLUS function details.
Page 23 01/01 08:00 Only Rate Mode 150.0 ml/h Infu. 00:08:30 5000 Time h:m:s Figure 2-5 Screen Interface Table 2-3 Screen Interface Description Table Number Description Display system time, Format: ―MM/DD HH:MM‖ Display infusion mode alternately, display charging status / battery remaining capacity Display infusion status (through doll’s states), rate, and can press MENU to enter the submenu: MENU button hidden during infusion...
Page 24 Details  Charging status / battery remaining capacity: A battery icon displayed when only battery-powered. A battery charging animation icon displayed when there is an external power supply and the battery is not fully charged. A fully charged battery icon displayed when there is an external power supply and the battery is full.
Page 25  Clear accumulated volume: press directly on the screen, or press the arrow keys and OK button to choose whether to clear accumulated volume or not in the submenu.  Set pressure class: press directly on the screen, or press the arrow keys and OK button to select pressure class in the submenu.
Page 26 Select Drug’s name Drugs Service Maintenance the equipment（password needed） Select and set user parameters （ password Settings needed） Include Operation Logs, Alarm Logs, Infu. Logs Logs return key Back to the previous menu 1、 Press MENU to enter. 2、 Use Arrow keys and ENTER/OK button to select and enter the submenu, or press directly on the screen to enter.
Page 27: Daily Use Procedures
2.5 Daily Use Procedures Press ON/OFF button Infu.Set installation PUSH Parameters setting Connect patient Start infusion End infusion Figure 2-7 Conventional Procedures Press ON/OFF button to turn the pump on. Select proper Infu. Set and discharge air bubbles in the infusion tube (an alternative way is using the PUSH function).
Page 28 Refer to the dynamic installation prompts figure to install the Infusion Set. Note: Refer to 3.2.2 for more information. PUSH to start PUSH, to stop , or automatically stop after the Press PUSH pre-set volume completed. Note: Refer to 3.2.2 for more information. Use last settings The user can choose ―Yes‖...
Page 29 9.1. Press ON/OFF button to stop infusion. 9.2. Disconnect the patient. 9.3. Open the pump door, remove the Infusion Set. 9.4. Replace the Infusion Set, install a new one and discharge the air bubbles inside it. 9.5. Connect the patient. 9.6.
Page 30 FOR YOUR NOTE 2-16...
Page 31: Chapter 3 Operation
Chapter 3 Operation 3.1 Before the Operation  Ensure the pump is properly positioned and secured（a maximum of 3 pumps can be stacked together）. The pump must be positioned on a level surface if used in combination with the short stand. Do not position the pump above the patient.
Page 32 In the process of self-test，the horn and buzzer rang, the alarm light first on a red, and then light yellow. If the above function is normal, the alarm self-test finished and function normal. HealFusion Version：1.00 Figure 3-1 Power initialization 3.2.2.3 System Time Setting...
Page 33 3.2.2.4 Door status After system time setting, the user can install infusion set according to the following steps: Hang the infusion bottle/bag on medical support, infusion bottle (bag) should be higher than the patient heart 20-80 cm. Choose the appropriate infusion set after the user hang up the infusion bottle (bag).
Page 34 3.2.2.5 Push If this is not the first time using the pump, and in the ―Settings-Default Settings‖ interface, ―Pop up push UI‖ is selected, then after the Infusion installation, the pump enters PUSH interface automatically. PUSH Rate is 500ml/h, it can be set in ―MENU-Settings-Manual Bolus Rate‖.
Page 35 Push Rate：500ml/h Vol. ：0.8ml Figure 3-3 PUSH 2 Or it will stop automatically after the pre-set volume completed. The PUSH volume will be reset when next PUSH process starts. 3.2.2.6 Use last settings If it is not the first time using the pump, and in ―Settings-Default Settings‖ we select ―Pop up Last Setting UI‖...
Page 36: Modes
Note: It will not appear for the first time. Till now, all the basic settings completed, enter screen interface. 3.3 Modes The Default Setting mode is Rate Mode. Press ―MENU-Modes‖ to enter mode selection interface. Modes Rate Mode Dosage Mode V-T Mode R-T Mode Trapezia Mode...
Page 37 3.3.1 Rate Mode Press ―Rate Mode‖, enter Rate setting interface. Or press the rate at the middle of main interface. According to whether the ―Enable Drip Rate Display‖ is selected or not, the interface is different. Set Rate (drops/min) 1 2 0 9 . 1 0 √...
Page 38 3.3.2 Dosage Mode Press ―Dosage Mode‖, enter the following interface: 剂量计算模式 Dosage Mode Drug: Insulin 药名：胰岛素体重：50.0kg Weight: 50.0kg 浓度：20.0IU/20ml Concentration: =1.00IU/ml √ 速率：4.0IU/h Rate: Dosage Mode =4.00ml/h Figure 3-9 Dosage mode The Drug, Weight, Concentration, rate are adjustable. Press the corresponding item, input the correct data and press to confirm.
Page 39 药量单位设置（20.0IU/20ml） Dose Unit Setting mmlo √ √ Figure 3-10 Dose Unit Setting Click the target unit, such as the virtual box back of ―mg‖ to select mg, then press to enter Dose Setting and Dilution Volume Setting interface: 药量设置（---mg/---ml） Dose Setting 0 0 0 0 0 .
Page 40 Click other dosage units will enter the above Settings interface, only the unit is different. Press to confirm and return the dosage mode interface. The detail steps to set rate are as follows: Press Rate item, and enter the Dose Rate Unit interface. The different dosage units corresponding to different dose rate unit, such as the dosage units for mg, press the Rate enter into the following interface: 选择剂量速率单位...
Page 41 预置量时间模式 V-T Mode 输液时间： Infu. Time: 1min VTBI: 预置量： --.--ml 注射速率：--.--ml/h Infu. Rate: √ Figure 3-14 V-T Mode Press the corresponding item, enter Infusion Time setting and VTBI setting interface. Infu. Time Setting(h:m) 1 2 : 0 9 √ Figure 3-15 Set Infusion Time VTBI Setting(ml) 1 2 3 4 .
Page 42  Press to confirm, enter V-T mode. Press key in the V-T Mode interface, then enter VIBI Finished Entry interface. The user can select Continue, Stop or Enter KVO Mode after finished. After confirmed, enter the screen interface, the system can work under V-T Mode.
Page 43 剂量计算模式 Trapezia Mode VTBI：--- Platform Rate：--- Rising Time：0s Falling Time：0s √ Dosage Mode Platform Time：--- Figure 3-18 Trapezia Mode The VTBI, Platform Rate, Rising Time and Falling Time are adjustable, Press the corresponding item, input the correct data and press to confirm.
Page 44 Press to confirm, return the main infusion interface, enter into Trapezia Mode. It is forbidden for any Bolus during Trapezia Mode process. Rising and falling stages are not allowed to change the rate, only in the maintenance phase rate of change and change to follow the principle.
Page 45 Single VTBI will update and display according to each parameter. The relevant parameters of gradient mode are as follows:  Total VTBI: 0.01~9999.99ml;  Number: 1~50;  Interval Time: 1s~99h59min59s;  Rate: 0.01~9999.99ml/h; Note: There was a ―Parameters Error‖ prompt character when the parameter is out of range. The detail setting steps can refer to Dosage Mode.
Page 46 The Weight, Concentration, Loading Dose, 1 Stage Time and 1 Stage Rate are adjustable, Press the corresponding item, input the correct data and press to confirm. The relevant parameters of loading dose mode are as follows:  Weight: 0.1~300kg；  Concentration: Dose Unit Setting, Dose Setting and Dilution Volume Setting are adjustable.
Page 47: Sequence Mode
online. If occur alarm lead to motor stalling during process, remove after the alarm, press start again, and then continue the last time breakpoint running. The rest of the alarm does not affect the infusion. 3.3.8 Sequence Mode Press ―Sequence Mode‖ (sequence mode), enter the following interface: 剂量计算模式...
Page 48: Relay Mode
预置量： --.--ml √ Figure 3-24 Relay Mode The equipment can continuously launch relay. This mode needs to be used with infusion information collection system manufactured by HEDY Medical Device Co., Ltd. 3.5 Settings Press ―MENU-Settings‖, enter user setting interface. 3-18...
Page 49 Settings VTBI Finish Setting Manual Bolus Setting Push Vol. Setting Power On Setting Vol.&Brightness Setting Figure 3-25 Settings 1 The user can press to enter the next page. Settings Auto -Lock Setting Cap Rate Setting Drip Rate Display Setting Bubble Size Setting IV Set Type Setting Figure 3-26 Settings 2 Press each individual in the menu, the user can enter the submenu to set all the...
Page 50: Vtbi Finish Setting
3.5.1 VTBI Finish Setting Press ―VTBI Finish Setting‖, enter the submenu, the user can choose any one of the next three ways to continue working after the VTBI is completed. VTBI Finish Setting Continue Stop Enter KVO Mode KVO Settings √...
Page 51: Manual Bolus Setting
3.5.2 Manual Bolus setting Press ―Manual Bolus Setting‖ to enter the Bolus Rate setting interface. Manual Bolus Setting 手动快推速率：150ml/h Bolus Rate: 手动快推液量：5.00ml Bolus Volume: √ Figure 3-29 Manual Bolus Setting The Bolus Rate and Bolus Volume are adjustable, Press the corresponding item, input the correct data and press to confirm.
Page 52: Power On Settings
管路冲注液量设置 Push Vol. Setting 1.0ml √ 2.0ml 3.0ml 5.0ml √ Figure 3-30 Push Volume Setting 3.5.4 Power On Settings Press ―Power On Setting‖, enter ―Please Enter Password‖ interface. Please Enter Password 5 6 6 1 √ Figure 3-31 Enter Password If the password is incorrect, there will be a reminder ―Password Error‖.
Page 53 Password Error √ Figure 3-32 Password Error Please contact the manufacturer to obtain the password. If the password is correct, enter ―Power On Setting‖ interface. If the password is correct, enter ―Power On Setting‖ interface. The user can choose to pop up these UIs: Default Settings Pop up Last Setting UI Pop up Push UI...
Page 54: Vol. & Brightness Setting
3.5.5 Vol. & Brightness Setting Press ―Vol. & Brightness Setting‖, enter ―Please Enter Password‖ interface. If the password is correct, enter Volume & brightness setting interface. Volume & Brightness Volume: Brightness: √ Figure 3-34 Volume & Brightness Alarm volume has 5 grades, press to decrease the volume, increase the volume, when adjust the volume, it is accompanied with voice prompt.
Page 55: Auto-Lock Setting
3.5.6 Auto-Lock Setting Press the up key on the panel + CLR more than 1s at the same time, the panel and the screen can be locked or unlocked. When it is locked, there has no response pressing the screen or pressing the panel, after unlocking, their functions recovery.
Page 56 Cap Rate(ml/h) 1 5 0 0 . 0 0 √ Figure 3-36 Set Cap Rate  Press to Increase values, to decrease values.  Or press arrow keys to select and increase / decrease values. If the parameter is out of range, there will be a reminder ―?Out of range‖. 数值超限...
Page 57: Drip Rate Display Setting
Drip Rate Display Setting Enable Drip Rate Display 15 drops/ml √ 20 drops/ml 30 drops/ml √ 输液管4 Figure 3-38 Drip Rate Display Setting If ―Enable Drip Rate Display‖ is selected, after the infusion rate set, the user can change its unit from ml/h to drop/min by pressing .
Page 58: Set Type Setting
3. Press to confirm the setting. Note: In the process of transfusion, the cumulative size of the bubbles (each more than 10ul) exceeds the limit size within 15min. It will occur ―Bubble Pass‖ alarm. 3.5.10 IV Set Type Setting Press ―IV Set Type Setting‖, enter IV set type setting interface. IV Set Type Setting √...
Page 59: System Time Setting
the start time of the day, and the volume & brightness during the day, the start time of the night, the volume and brightness during the night. Day & Night Setting Daytime Start: 05:00 Daytime Setting Nighttime Start: 18:00 Nighttime Setting Figure 3-41 Day &...
Page 60 Date (YY/MM/DD) 1 5 / 0 7 / 1 0 √ Figure 3-42 Date Setting After confirm date setting, enter time setting interface. Time setting format ―HH:MM:SS‖, refer to date setting procedures to set values. Time (HH:MM:SS) 1 5 : 0 7 : 1 0 √...
Page 61: Extended Iv Set Calibration
Extended IV Set Calibration Accuracy Calibration Pressure Calibration √ Figure 3-44 Extended IV Set Calibration Press ―Accuracy Calibration‖. Accuracy Calibration Please Install IV Set without Bubbles Start Calibrating Enter Volume √ --.-- Figure 3-45 Accuracy Calibration Install IV Set without Bubbles, put the liquid outlet in the measuring cup(25ml) or the container on the balance.
Page 62: System Version
Pressure Calibration Connect to the Testing Equipment Start Calibration √ Figure 3-46 Pressure Calibration Connect the iv Set to the testing equipment (such as pressure gauge), press‖ Start Calibrating‖. Press ―Mark 30kPa‖ when the pump displays ―Mark 30kPa‖, Press ―Mark 100kPa‖ when the pump displays ―Mark 100kPa‖. The screen displays ―Calibration Completed‖, Press to confirm and return to the previous menu.
Page 63: Operation Logs
Logs Operation Logs Alarm Logs Infu. Logs Figure 3-47 Logs The contents of the log are not going to disappear after the alarm system has experienced a total loss of power for a finite duration. The pump will eliminate the earliest log as it reaches capacity. 3.6.1 Operation Logs Operation log shows the operate time and date, and what the user set.
Page 64: Alarm Logs
3.6.2 Alarm Logs Alarm log shows the time and date when alarm occurs, and why the alarm occurred. Press ―Alarm Logs‖ to enter the interface. Alarm Logs 2015/04/05 11:30:19 !!! Battery Empty 2015/04/02 16:39:33 ? Out of range 2015/04/02 11:30:19 ! External power off 2015/04/01 10:30:19...
Page 65: Drugs
Infu. Logs Time Interval Drug Info. Infu. Logs 04/12-08:00:13 50ml/h 5mg/50ml 04/12-09:25:13 1.01ml 16:39:33 Figure 3-50 Infusion Logs The format is: time Drug information —— Start time Rate (ml/h) —— Stop time Volume (ml) 3.7 Drugs Press ―MENU-Drugs‖, enter the drugs interface: 药物库...
Page 66: Service
药物库胰岛素 Insulin !!! Battery Empty 药物浓度： Concentration: 20.00IU/20ml =1.00IU/ml Default Rate: 默认速率： 4.00IU/h √ Figure 3-52 Drug’s information Press the number key on the right, such as to check out other information page. All the information parameters including Concentration, Default Rate, Dose Rate Hard Limit, Manual Bolus Vol.
Page 67: Chapter 4 Technical Data
Chapter 4 Technical Data 4.1 Infusion Accuracy  The maximum capacity flowing through under single fault condition is less than 1ml.  Under normal circumstances, the infusion precision of the Infusion pump is as the following: Table 4-1 Infusion Control Parameters Infusion Control Parameter Rate Range Rate...
Page 68: Kvo Mode
If the Infu. Set used is untested varieties, or used under other unusual circumstances, such as too short circle time, abnormal transfusion characteristic, Inadequate protection under harsh environmental conditions, tube WARNING! plugging and backflow, the pump may unable to maintain the accuracy. ...
Page 69: Blocking Threshold
Table 4-3 KVO Protection Performance Parameter Range KVO Protection Control Parameters 0.1～5.0 ml/h KVO Rate 4.3 Blocking Threshold In order to ensure the safety of the patients, the pump has Occlusion alarm function, when the pressure in the infusion tube is greater than the blocking threshold, it will alarm.
Page 70 12.67 00:00:05 0.01 62.4 00:00:44 0.16 137.87 00:07:41 0.33 16.93 00:04:43 0.015 69.83 00:25:11 0.171 136.83 03:25:23 0.358 11.33 00:12:37 0.023 66.4 2:02:55 0.19 138.8 11:09:03 0.416 Note: the Occlusion pressure and Occlusion alarm time are related to the Infusion brand, infusion tube, pressure calibration coefficients and the test equipment.
Page 71: Chapter 5 Alarm And Tips
Chapter 5 Alarm and Tips 5.1 Alarm Function Alarm function’s operating environment is the same as the equipment’s operating environment. Alarm Silence: the user can press CLR to silence the alarm for 2 minutes. Alarm Acknowledge: All the alarms can be confirmed by pressing OK. Only after acknowledging alarm can message be cleared and back to the previous interface (except the Install Infu.
Page 72: High-Level Alarm
intermediate-level and low-level alarm. Different priority alarms have different sound and light signals. All alarms are technical type. This section will detail the cause of the alarm and the corresponding solutions. If there is more than one alarm occurring at the same time, high priority Alerts appear first depending on the alarm priority.
Page 73 In the process of Infusion pump Bubble transfusion, the size of the automatically stop Pass single bubble, or the size infusing. Press OK to of the bubbles (15min) confirm the alarm. exceeds the limit size. The velocity /BOLUS rate Press OK to confirm the exceed the limit value of alarm.
Page 74: Intermediate-Level Alarm
normal. Near Empty In the infusion process, the Press OK to confirm the IV set will soon be empty alarm. The infusion will is detected. be continued. The user can stop the infusion after confirming the alarm. 5.2.2 Intermediate-level Alarm The intermediate-level alarm occurs when there are some bad effects in the normal work, it means that the device’s work has been done, and the medical personnel need to do the next step.
Page 75 is on and the screen displays relevant information. Low-level alarm includes the following types: High-level Alarm Alarm Cause Solution Battery Low In the case of no First, press OK to external power confirm the alarm. supplied, and the Second, connect the remaining capacity can external power supply.
Page 76: Alarm Acknowledgement Reference Table
(select to continue infusion when VTBI completed). Note: The following alarms are non-latching alarm signal, and others are latching alarm.  Battery Low  External power supply interruption  Infu. Near Finished 5.2.4 Alarm acknowledgement reference table optical signal Alarm Audible Staff User confirmation...
Page 77 VTBI completed, Continue Infusing.  Cause: In the process of transfusion, VTBI completed is detected (select to continue infusion when VTBI completed). Out Of Range  Cause: In the parameter setting interface, the value is set out of the allowed range. Password Error ...
Page 78 FOR YOUR NOTE...
Page 79: Chapter 6 Maintenance
Chapter 6 Maintenance 6.1 Cleaning/Disinfection Power off and unplug the system before cleaning the equipment. CAUTION! The system should be wiped with the following liquids dipped soft cloth at least once every month for cleaning.  50% NaClO  10% HClO ...
Page 80: Maintenance
6.2 Maintenance  Equipment should store at the specified temperature, humidity and other external conditions.  Observe the pump’s statue to find and solve problems timely. No modification of this equipment is allowed. WARNING! This equipment shall not be serviced or maintained while in use with the patient.
Page 81: Appendix A Start-Up Curves And Trumpet Curves
Appendix A Start-up Curves and Trumpet Curves The following are the Start-up Curves and Trumpet Curves @different infusion speeds (infusion time: 2h). Solution: Ⅲ grade water. Test temperature: 23±2℃. Figure A-1 Start-up Trend. @1ml/h Figure A-2 Trumpet Curve. @1ml/h...
Page 82 Figure A-3 Start-up Trend. @25ml/h Figure A-4 Trumpet Curve. @25ml/h The graphs show the accuracy/uniformity of flow in relation to time. They allow for the following: The delivery behavior or delivery precision is essentially influenced by the type of the disposable used. Deviations from the technical data of the pump cannot be excluded if lines (disposables) other than those stated in the order data are used.
Page 83 The above graphs show the test’s results, which can be used as an important symbols of comprehensive characteristic of the pump. The above data is tested by the same infusion pump, and each test using new infusion set, a total of 2 infusion set. ...
Page 84 FOR YOUR NOTE...
Page 85: Appendix Bemc Information
Appendix B EMC Information Accompanying Documents: Instructions for use  Model i7/ip-3 needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS;  Portable and mobile RF communications equipment can affect model i7/ip-3.
Page 86 Normative references: Guidance and manufacturer’s declaration – electromagnetic immunity The model i7/ip-3 is intended for use in the electromagnetic environment specified below. The customer or the user of the model i7/ip-3 should ensure that it is used in such an environment. Electromagnetic Immunity IEC 60601...
Page 87 variations 40 % U 40 % U requires continued on power (60 % dip in (60 % dip in operation during power supply mains interruptions, it is input lines for 5 cycles for 5 cycles recommended that the model i7/ip-3 be powered 61000-4-11 70 % U 70 % U...
Page 88 Normative references (Continued) Guidance and manufacturer’s declaration – electromagnetic immunity The model i7/ip-3 is intended for use in the electromagnetic environment specified below. The customer or the user of the model i7/ip-3 should ensure that it is used in such an environment. Electromagnetic environment –...
Page 89 watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the...
Page 90 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Page 91 Normative references (Continued) Guidance and manufacturer’s declaration – electromagnetic emissions The model i7/ip-3 is intended for use in the electromagnetic environment specified below. The customer or the user of the model i7/ip-3 should ensure that it is used in such an environment. Electromagnetic environment –...
Page 92 Recommended separation distances between portable and mobile RF communications equipment and the model i7/ip-3 The model i7/ip-3 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model i7/ip-3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model i7/ip-3 as recommended below, according to the maximum output power of the communications equipment.
Page 93: Appendix C Abbreviations
Appendix C Abbreviations Alternating Current Cap Rate The upper limit of the rate Clear direct current Electromagnetic Compatibility Infu. Infusion Keep vein open Radio frequency RS232 recommend standard 232 R-T Mode Rate-Time Mode SIP /SDP Session Initiation Protocol/Session Description Protocol User Interface VTBI Volume To Be Infused...