SN-50C6 Nutrisafe 2 User Manual Ver 2.3

Contents 1. SAFETY INFORMATION 1.1 Indication for User Manual 1.2 General Introduction to Safety 1.3 Electric/Mechanical Safety    1.3.1 Electric Safety    1.3.2 Operating Safety 1.4 Symbols and Labels    1.4.1 Safety Symbols    1.4.2 Transportation Symbols    1.4.3 Equipment nameplate    1.4.4 Applicable Standards List 2. PRODUCT INTRODUCTION 2.1 Provisions 2.2 Model Coding 2.3 Working Principle 2.4 Technical Characteristics and Parameters    2.4.1 Setting range of flow rate   2.4.2 Accuracy    2.4.3 Purge rate    2.4.4 Display range of volume delivered    2.4.5 Setting of delivery limit    2.4.6 Occlusion detection pressure    2.4.7 History Record   2.4.8 Alarms    2.4.9 Power Supply   2.4.10 Environment    2.4.11 Overall Dimensions:    2.4.12 Net Weight 2.5 Compositions    2.5.1 Compositions and Part Introduction of SN-50C6 System 2.6 How to Use SN Serial Syringe Pump   2.6.1 Startup    2.6.2 System Self-test for Startup    2.6.3 Loading Syringe    2.6.4 Flow Rate Setting    2.6.5 Delivery Limit Value Setting    2.6.6 Occlusion Detection Pressure Setting    2.6.7 Syringe Code Selection    2.6.8 Fast Feeding    2.6.9 Delivered Volume Query    2.6.10 Alarm Prompt    2.6.11 Syringe Calibration    2.6.12 Standard RS232 Interface 4

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   2.6.13 Device Fixation 3. TROUBLESHOOTING 4. MAINTENANCE 5. INFUSION CHARACTERISTICS 5.1 Infusion Accuracy of Pump 5.2 Occlusion Response Characteristics 6. PRODUCT STANDARD CONFIGURATION 7. RELATED INFORMATION

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1. Safety Information 1.1 Indication for User Manual In this manual, the following information is used for emphasizing the related information or potential risk to patients or equipment. Caution: Used for indicating the possible caused damage to the equipment or environment Warning: Used for indicating the possible caused injury or death. Attention: Used for emphasizing the important instructions. These instructions relates to how to use the manual and the product, or providing the additional information like detailed explanations, prompt or reminding.

1.2 General Introduction to Safety According to the electric safety classification, this is a Class I, CF type, non-portable equipment with internal power supply. The pump is a splash-proof device at IPX4 class. Syringe: The users are required to use the syringe meeting national standards with medical admittance license. The default is Shandong Weigao Jierui branded syringe at specification of 10mL, 20mL, 30mL, and 50mL. The userdefined syringe can also be used through “Automatic syringe calibration” function, please see 2.6.11 in the Manual. The followings are the brief introduction to safety precautions: • Operators are required never to open the casing of the device. • Never to cause malfunction or short circuit to the safety parts in the built-in device. • Even in case of abnormal operation of the device, unauthorized maintenance is prohibited. It is required to immediately contact the qualified and authorized personnel from Sinomdt. The authorized maintenance personnel can ask for the corresponding data from our company including circuit diagram and parts 6

list, etc. • There are no components required for maintenance inside the device. • It is required to follow all the warnings and cautions, no matter they are specified or implied. • It is required to follow all the instructions on safety label. 1.3 Electric/Mechanical Safety The maintenance personnel who have passed the training held by Sinomdt are required to open the casing, change battery and mechanical parts. Otherwise, safety problems of the device may be caused. The followings are the brief instruction to the warning information.    1.3.1 Electric Safety Warning: Risk of electric shock: For protecting patients and medical staff, secure grounding for the device and power supply socket is required. Connecting 2-pin plug to the 3-core cable is prohibited. Warning: Risk of electric shock: It is prohibited to open the casing of the device during operation or with power connection. The authorized technicians are required to open the casing. Caution: Before using, the customers are required to check if there is obvious damage on the device and cables those possibly cause danger to patients or lower performance of the device. It is recommended to make regular check at frequency of once a week or more. In case of obvious damage found, it is recommended to change the damaged parts before using. Caution: Regular safety test is required for the device including leakage current test and insulation test. It is recommended to the test it at frequency of once a year or to follow the requirements as per regulation and test specification.

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Caution: Power disconnection is required before starting cleaning. Cleaning methods: clean the device surface with a soft brush or a piece of soft cloth; clean the connector or panel edge with a brush or a piece of cloth soaked in neutral cleanser/ cold disinfectant or 70% alcohol or isopropyl alcohol. Prevent the cleanser or disinfectant from coming into the device. Pay more attention to the connector and panel edge.    1.3.2 Operating Safety Warning: It is required to operate the device in the specified environment. Otherwise, abnormal operation to the device will be caused. Specified working conditions: Working temperature: +5 ~ +40° Relative humidity: 20% ~ 80% Atmospheric pressure: 86kPa ~ 106kPa Power: AC 110 ~ 230V; (50 ~ 60Hz)±1 Hz Max. power: 30VA (SN-50C6), 30VA (SN-50C6T), 40VA (SN50F6) Warning: It is not suitable to be operated in an environment with oxygen gas and containing flammable anesthetic of nitrogen oxide. Otherwise, there is the risk of explosion. Warning: Using improper or non-calibrated syringe probably cause inaccurate speed or injection amount. Warning: It is required to prevent air from entering human body during using this device. Caution: Keep the environment clean; avoid vibration; keep it away from corrosive medicines, dust, and environment with high temperature and humidity. Caution: Electromagnetic interference: Make sure to keep the operation environment of the device free from strong electromagnetic interference, e.g. the interference caused by telegraphy machine and mobile phone. 8

Caution: This device is not suitable for the injection of the following medical solution: --Insulin --Chemotherapy drugs. Reminding: When RS232 port not in use should be covered with protective cover. 1.4 Symbols and Labels    1.4.1 Safety Symbols “On/Off” or power-on Functional grounding

Protective grounding

High voltage Refer to attached documents CF type application part AC Battery level Manufacturer

European authorized representative

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Date of production

Serial number CE certification mark. The digital code of the mark is the code of the certification institution. Sinomdt’s logo Mark for non-recycle.

   1.4.2 Transportation Symbols Fragile: Be careful

Keep dry

Storage humidity: Do not expose the product in the environment at humidity beyond the specified value. Temperature: Do not expose the product in the environment at temperature beyond the specified value. Direction: with this side up

   1.4.3 Equipment nameplate

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   1.4.4 Applicable Standards List Harmonized Standard

Description

ISO 14971:2007

Medical devices - Application of risk management to medical devices

EN 980:2008

Graphical symbols for use in the labelling of medical devices

EN 1041:2008

Information supplied by the manufacturer with medical devices

EN 60601-1:1995+A1+A2

Medical electrical equipment - General requirements for safety

EN 60601-1-2:2007

Medical electrical equipment - General requirements for safety - Collateral standard: Electromagnetic compatibility; Requirements and tests

EN 60601-1-4: 1996

Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems

EN 60601-2-24:1998

Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers

2. Product Introduction 2.1 Provisions SN-50C6 – Nutrisafe 2 syringe pumps are the volumetric injection pumps with multi-channel and multi-speed control. The product features high precision of timing, stable flow rate and less quantity of liquid required. The product is suitable for enteral solution only. SN-50C6 – Nutrisafe 2 syringe pump use 10mL, 20mL, 30mL or 50mL disposal sterile syringes (hereinafter collectively referred to as syringe) calibrated by the device. In case of clamping the syringe on to the device, the device will automatically identify the specification of the syringe clamped. In addition, the device is equipped with multi alarming functions for achieving a safe and reliable injection. The products are for control on delivery volume and flow rate during clinical solution injection (medicine liquid, nutrition liquid) into the body of patients.

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2.2 Model Coding SN - 50 C6 Model identification Product serial identification Company’s code 2.3 Working Principle This is a volumetric pump different from the constant pressure pump (e.g. peristaltic pump). The output of solution within a certain period will not be affected by the resistance in the infusion channel. When the pressure reaches a certain value, the occlusion alarming system equipped on the pump will give sound, light alarm and stop running, meaning that the actual output volume complies with the preset output volume. The device is equipped with a micro-feeding system. In virtue of the circuit, this system can obtain a larger speed adjustment range. Once any of the four kinds of syringe with specification of 10mL, 20mL, 30mL or 50mL is installed on to the device, the identification system will automatically adjust ready the proper flow rate up limit. At this time, as long as to set ready the desired injection speed and press the startup key, the device will start operation. 2.4 Technical Characteristics and Parameters    2.4.1 Setting range of flow rate 50mL syringe:0.1 ~ 1500mL/h; 0.1mL/h per step when rate is under 1000mL/h, and 1mL/h per step since 1000mL/h 30mL syringe: 0.1 ~ 900.0mL/h; 0.1mL/h step 20mL syringe: 0.1 ~ 600.0mL/h; 0.1mL/h step 10mL syringe: 0.1 ~ 400.0mL/h; 0.1mL/h step   2.4.2 Accuracy Accuracy of flow rate: within ±2% (the accuracy of syringe should be within ±1%.) Mechanical accuracy: within ±1%    2.4.3 Purge rate 50mL syringe: 1500mL/h; 30mL syringe: 900.0mL/h; 20mL syringe: 600.0mL/h; 12

10mL syringe: 400.0mL/h    2.4.4 Display range of volume delivered 0.1-9999mL, For 0.1~999.9mL, the display resolution is 0.1mL; and for those over 1000mL, it is 1mL.    2.4.5 Setting of delivery limit 0.1mL-9999mL, 0.1mL step when value is under 1000mL; and for those over 1000mL, it is 1mL step.    2.4.6 Occlusion detection pressure High (H): 800mmHg±200mmHg (106.7kPa±26.7kPa) Center (C): 500mmHg±100mmHg (66.7kPa±13.3kPa) Low (L): 300mmHg±100mmHg (40.7kPa±13.3kPa)    2.4.7 History Record These serial products can maximally store 1000 pieces of history records. The record includes the following information: flow rate, alarm data, total volume delivered, pipeline occlusion pressure, delivery limit and syringe specification.   2.4.8 Alarms For a safe and reliable infusion, these serial products are equipped with the following alarm functions: ‘Occlusion’, ‘Nearly empty’, ‘Finish’, ‘Syringe dislocated’, ‘Plunger/Clutch disengaged’, ‘Battery low’, ‘Battery exhausted’, ‘Power cable disconnected’, ‘Flow rate over limit’, ‘Volume over limit’, ‘System error’, ‘Non-operation time over’, please refer to 2.5.9 for further details.    2.4.9 Power Supply Power Voltage: AC.110V ~ 230V Power frequency: (50 ~ 60) Hz±1Hz Battery voltage: Rated DC.12V Battery capacity: A fully charged battery can support a channel working at the speed of 5mL/h for more than 6 hours. Maximum power: 30VA (SN-50C6) Operating method: intermittent load continuous operation 13

  Note: Before the first time of use, the battery must be charged for minimum 12 hours.   2.4.10 Environment Working conditions: Temperature: +5°C / +40 °C Humidity: 20% - 80% Conditions for transportation and storage: Temperature; -20°C / +55°C Humidity: ≤ 95%    2.4.11 Overall Dimensions: Syringe pump SN-50C6

306mm (W) × 135mm (H) × 127mm (D)

Single channel

   2.4.12 Net Weight SN-50C6: 2.3kg (including clamp); Note: This serial syringe pumps simultaneously store 48 types of syringes ( 12 types for each size of 10mL, 20mL, 30mL and 50mL syringes ). Through automatic calibration function, all brands of those 4 size syringes can be supported in this pump. 2.5 Compositions SN-50 serial syringe pump is composed of the casing, syringe clamp, control plate, and pusher. Refer to the table for the model and dimensions; refer to the figure for product structure.    2.5.1 Compositions and Part Introduction of SN-50C6 System

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2.6 How to Use SN-50C6 Syringe Pump   2.6.1 Startup After connecting utility power (AC) through, AC power indicator lights, and then the pump is in power-on state.    2.6.2 System Self-test for Startup After pressing power key for 1.2 seconds, the system starts self-test. In case of no ERR displayed on the LED digital display, it means a normal pump. At this time, the device is in a standby state. At this time, if to press and hold key, the device enters a hibernation and power saving state. At this time, the four-bit LED digital display shows the sign of “-” in turn. Press any key of this channel except key to enable this channel. And, if press the power key for 1.2 seconds, the device will power-off. In injection status, first need to press key to stop injection, then press key to power off.    2.6.3 Loading Syringe • After filling up the syringe with solution and expelling air out, then put the syringe into the syringe holder. Warning: Before installing the syringe, it is required to expel air out of the syringe to avoid air embolism. Caution: The barrel of the syringe is required to be inserted into the injection pump barrel fixation slot.

• Fix the syringe barrel securely with the syringe clamp; hold tightly the pusher to make the clutch open; move the pusher to the end of the syringe handspike; loosen the pusher to release the Clutch and to lock the syringe push plate between the pusher and the Clutch. • Press and hold the Fast Forward key and do not release it until solution coming out from the needle tip. • After setting all the parameters ready then press key. Thus, the pump starts infusion.    2.6.4 Flow Rate Setting • After power on, the pump use the last set flow rate as the default flow rate, 16

and the user can use the four setting keys to set infusion flow rate, and the corresponding values will be shown on the LED display. • are the quick setting keys; are the slow setting keys; in pause state, press and hold to quickly adjust the flow rate faster. or Press and hold to adjust the flow rate slower. or • Setting can be performed only in standby or pause state. After startup, all the flow rate adjustment keys are locked.    2.6.5 Delivery Limit Value Setting Delivery limit value setting is for setting the limit value of total infusion volume. • In standby or pause state, use key to enter delivery limit value setting state. At this time, indicator lights, and LED displays the current limit value. At this time, the four setting keys can be used for adjusting the limit value for total infusion volume and the corresponding values are shown on the LED display. In startup state, the datum is locked. At this time, after pressing key, only the set limit value can be viewed. • In standby or pause state, simultaneously press key and key, the set limit values will be reset.    2.6.6 Occlusion Detection Pressure Setting • There are three levels of occlusion detection pressure: High (H), Center (C), and Low (L). The pump use the last set pressure level as the default after power on. • In standby or pause state, use key to enter occlusion detection pressure setting state. At this time, LED will display OCCL. Press or to switch among (H), (C) and (L).    2.6.7 Syringe Code Selection • If the syringe is not installed, pressing key will cause Syringe dislocated’ alarm; if the syringe code is not set, after pressing key, the device will automatically set to the code of same syringe specification as the previous time and start infusion. • In standby or pause state, use key to enter syringe code setting. At this time, ‘- XX -’ will be shown on the LED display. ‘XX’ indicates the syringe code. Press or to select the desired syringe code in the syringe code list.    2.6.8 Fast Feeding There are two kinds of fast feeding: • The volume of fast feeding is NOT added up to the total volume. 17

In standby or pause state, after pressing and holding key, the device will perform infusion at the preset purge rate. At this time, the fast feeding solution volume is not added up to the total infusion volume. LED display shows the fast feeding infusion flow rate of the current syringe specification; after releasing key, the LED display will be back to display the originally set flow rate. • Fast feeding volume is added up the total volume. When the device performs infusion at a certain and normal speed, after pressing and holding key, the fast feeding solution volume is added up to the total infusion volume. At this time, the device dynamically adds up the output of the pump: in case of total volume measurement is below 1000mL, it is to increase by unit of 0.1mL; after the total accumulated volume reaches 1000mL, it is increase by unit of 1mL.    2.6.9 Delivered Volume Query • In any state, it is able to check the total infusion volume of solution into the patients’ body by pressing key. • In any state, it is able to press key and key to reset the total infusion volume.    2.6.10 Alarm Prompt • Nearly Empty: When the residual amount of solution reaches to 1.5mm±0.8mm, the indicator on the panel flashes and gives voice alarm with interval at the same time. • Finish: When the solution in the syringe is almost finished, indicator flashes with voice alarm at interval, and the LED digital display shows KVO flow rate of 0.5mL/h. At this time, the pump enters KVO infusion mode. • Occlusion: In case of unsmooth infusion caused by occlusion needle or bended pipeline, when the liquid pipeline system reaches to the set threshold value, the indicator on the panel flashes with voice alarm at interval. At this time, pressing key the alarm will be mute. Note: There is a course from being entirely occlusion to alarm given for the occlusion alarm of the syringe by most of manufactures. Along with the rise of pump output, the system pressure increases. When the system pressure reaches to the set pressure value, occlusion alarm starts up.

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• Syringe Dislocated: During normal infusion, if the syringe clamp is not pressed on the syringe properly, the pump will give voice alarm at interval with flashing indicator and stop working. • Plunger/Clutch Disengaged: If the push plate of the syringe is not locked between the push head and clutch, or the clutch is not closed, the pump will give voice alarm at interval with flashing indicator after starting up the infusion. The device can not enter infusion state. During normal infusion, if to press down the push head, the clutch will open. Then, the pump will give voice alarm at interval with flashing indicator and stop working. • Flow Rate Over Limit: If the set speed is over the range of flow rate of 10mL, 20mL, and 30mL, pressing key can not start up the pump. The LED display will show the flow rate setting value of 10CC, 20CC, and 30CC respectively in turn and it gives voice alarm at interval. • Volume Over Limit: When the solution amount of the pump reaches to the set limit value, the pump will give voice alarm at interval. At this time, the pump stops working, the speed value and limit value will be shown on the LED display alternately. The limit value is displayed with voice alarm. • Power Cable Disconnected: After switching power on, if AC power supply is not connected through or poor contact of power cord occurs during using, indicator flashes (All the three block flash.), the pump will give voice alarm at interval. • Battery Low: In case of low battery, indicator flashes (One block flashes.) the pump will give voice alarm at interval. At this time, the pump is still able to work for about 30 minutes at the flow rate of 5mL/h. • Battery Exhausted: When the battery electricity is totally exhausted, the pump will stop working. indicator flashes (All the three block flash.) the pump will give voice alarm at interval. • System Error: Mis-operation may cause program error. At this time, “ERR” will be shown on the LED digital display with voice, light alarm at interval. After pressing 19

key to power off the device for restart, if it is still with system error alarm, please contact the authorized service provider in your region or Sinomdt company. • Non-operation Time Over: In status of power on, in case of no any operation for more than 2 minutes, the pump will give interval voice alarm and show “NOOP” at LED, then press key to enter sleeping mode, or press key to remove this alarm. If continually occur this alarm, after the second time press key, the pump will show “NOOP” but without voice. • Silence: Except the Battery Exhausted alarm and Power Cable Disconnected alarm, all the other alarms can be mute by pressing key. In case of no operation for longer than 2 minutes after mute, the voice alarm will be given again. Except Battery Low alarm and Battery Exhausted alarm, it is to press key to remove alarm and enter pause state.    2.6.11 Syringe Calibration • The unit of syringe calibration: mL/h, mmHg or kPa • In standby or pause state, pull the syringe plunger to be calibrated to the position of roughly 5mm over the rated scale line (Fully filling up with water is required. It is also required to be connected securely with extension tube for ensuring the accuracy of the calibration.) and are to be properly clamped on the device. • Press and hold key to push the plunger to the rated capacity scale line (10mL, 20mL, 30mL or 50mL) of the syringe. Release key. • Press and hold key to enter calibration state of the syringe. At this time, the infusion state indicator of flashes at the same time; release key. At this time, the LED display shows the code of the current calibrated syringe on this channel on this device, the user also can press or to set the desired code for the calibrated syringe. • After pressing key, the syringe starts automatic calibration. During the automatic calibration process, to avoid calibration fail, please do not operate the device. • When the plunger is pushed to the end, the device beeps at interval and automatically comes to pause state. Then calibration is completed.    2.6.12 Standard RS232 Interface • Standard RS232 interface is equipped on the pump for bi-direction communication. Shield cable is required for RS232 communication. The device connected to the RS232 interface is required in compliance with the requirements as per the standard of IEC60950-1:2005. If needed, please ask for RS232 interface 20

protocol from Sinomdt company for further details. The device connected to this device must be the designated device by Sinomdt company.    2.6.13 Device Fixation • By turning the fastener on back of the device, it is to fix the device vertically or horizontally on the supporting pole or bed frame. • Refer to the following figures for the method to fix it on the vertical supporting pole. Press the cover at rotor shaft to open the fastener at an angle of 90°; turn the handspike to clamp tightly the supporting pole.

Figure 2.6.13.1: Open the fastener

Figure 2.6.13.2: Clamp tightly the supporting pole • Refer to the following figures for the method to fix it on the horizontal supporting pole. Turn the whole fastener counterclockwise at an angle of 90°; press the rotor shaft cover to open the fastener for 90°; turn the handspike to clamp tightly the supporting pole.

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Figure 2.6.13.3: Turn for 90°counterclockwise

Figure 2.6.13.4: Open the fastener

Figure 2.6.13.5: Clamp tightly the supporting pole Attention: Warning: after long term of use, in case of the recess of the membrane, please notify the manufacturer to change. Otherwise, mis-triggering may be caused.

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Warning: because the recessed plastic lamination of keys after long term of use will possibly cause mis-triggering, after completing pressing the fast forward key, it is recommended to carefully check if the speed goes back to the originally set value. If it is the same as the fast forward speed, it is required to power off. Otherwise, the pump will keep an infusion at purge rate. That causes danger to patients. At this time, please notify the authorized maintenance personnel for change the key lamination. Warning: in case a broken clutch on the push head, please change it timely. Otherwise, siphon will be caused making the residual solution automatically flow into the body of the patients. Excessive medicine infusion will cause harm to the patients. Warning: the syringe barrel must be placed into the fixation slot. Otherwise, infusion without medicine or large amount medicine infusion by siphon will cause harm to the patients. Warning: it is a must to use the syringes with the specification and model accurately calibrated by the device. Otherwise, unreliable infusion speed and incomplete infusion may occur. For the designated syringes, we recognize only their overall dimensions and structure. Their biochemical, physical and measuring indexes must be tested and approved by the related supervision authorities. Warning: while moving the syringe pump, it is required to pay attention to the connection of syringe, extension tube and needle to avoid harm against the patients caused by poor contact of the connectors. Warning: clamping installation following the requirements as shown in the figure or automatic sure fixation is required for the pump. It is prohibited to place it on a flat board without railing by bed. This is to prevent the pump from falling by pulling the pipeline and causing danger to the patients. Warning: operation of the pump by unauthorized personnel is prohibited to avoid danger caused to the patients. Attention: for testing the speed of the pump, it is required to use the selected syringe.

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