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MEDCAPTAIN ELFensor P3 User Manual

Ambulatory infusion pump
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MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer : MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer Address: 12th Floor, Baiwang Research Building,
No.5158 Shahe West Road, Xili, Nanshan, 518055
Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA
Production Address: Building C, Jiale Science and Technolog y
Industrial Park , Matian Street , Guangming, 518106
Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA
Tel: +86-755-26953369
Website: http://www.medcaptain.com
E-mail: mc.ser vice@medcaptain.com
P/N：H-1480-00572-01
V1.0
ELFensor P3/ELFensor P6/ELFensor P9
Ambulatory Infusion Pump
User Manual
MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.

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Summary of Contents for MEDCAPTAIN ELFensor P3

  • Page 1 ELFensor P3/ELFensor P6/ELFensor P9 Ambulatory Infusion Pump User Manual MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Manufacturer : MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD. Manufacturer Address: 12th Floor, Baiwang Research Building, No.5158 Shahe West Road, Xili, Nanshan, 518055 Shenzhen, Guangdong, PEOPLE'S REPUBLIC OF CHINA...
  • Page 2 MEDCAPTAIN reserves the final interpretation right to this manual. To ensure high accuracy and efficiency of its products and services, MEDCAPTAIN shall have the right to change the contents of this manual without prior notice under the premise of complying with medical device regulations.
  • Page 3 Item Meaning Boldfaced Indicates controls on the control panel, or on-screen objects such as menu items or Word keys. > Select a menu item or a key following the path.
  • Page 4 Thanks for purchasing the MEDCAPTAIN product. ● MEDCAPTAIN provides a limited warranty on the product. Within the warranty period, after-sales services for the product are provided free of charge. The length of the warranty period is stipulated in the sales contract. For details, contact your local distributor. However, a product damage or failure is not covered by the warranty if it is caused by: −...
  • Page 5 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 6: Table Of Contents

    Contents 1     O verview ����������������������������������������������������������������������������������������������������������������������������������1 1.1 Intended Purpose .......................... 1 1.2 Intended Users ..........................1 1.3 Intended Patient Population ......................1 1.4 Contraindications ......................... 1 1.5 Indications ............................ 1 1.6 Undesirable Side-effects ......................1 1.7 Clinical Benefits ........................... 1 1.8 Product Features ........................... 2 2    ...
  • Page 7 Contents 6.7.2 Editing Parameters ......................... 35 6.7.3 Viewing Report ..........................36 6.7.4 Clearing the Volume Infused ......................36 6.7.5 Setting Pain Scores ........................36 6.7.6 Selecting Adverse Reactions ......................37 6.7.7 Performing Quick Settings ......................37 6.7.8 Viewing Vital Signs ........................37 6.7.9 Starting a Demand Dose ........................
  • Page 8 Contents Appendix  D  Parameter Units ��������������������������������������������������������������������������������������������������69...
  • Page 9 T h i s p a g e i s i n t e n t i o n a l l y l e f t b l a n k .

  • Page 10: Verview

    1     O verview 1�1 Intended Purpose This product is intended to deliver medications to patients through intravenous, intra-arterial, subcutaneous, intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space. Total parenteral nutrition (TPN) is limited to intravenous infusion. 1�2 Intended Users The pump can be used in medical settings, like hospitals, clinics, nursing homes, and homecare...

  • Page 11: Product Features

    ● Multiple infusion modes. ● Maximum infusion rate of 500 ml/h (for ELFensor P3/P6) or 800 ml/h (for ELFensor P9). ● Minimum infusion rate increment of 0.1 ml/h. ● Squeeze mechanism that squeezes the infusion tubing to realize liquid flow during infusion.

  • Page 12: Afety

    2     S afety This chapter describes important precautions for operating the ELFensor P3/P6/P9 ambulatory infusion pump. To ensure the safety of both the operator and the patient, read this chapter carefully before using the pump. You should be fully aware of the precautions provided in this manual.
  • Page 13 2 Safety ● If a battery stinks, has a high temperature, deforms, changes color, or encounters other exceptions during use, charging, or storage, stop using the battery immediately and take it out of the battery compartment. If necessary, contact the after-sales service department of the manufacturer.

  • Page 14: Symbol Description

    2 Safety ● Do not use the pump in a strong electric or magnetic field or near mobile radio-frequency communication equipment as this may compromise the performance of the pump or cause a fault. ● Do not stack the pump with other equipment as this may compromise the performance of the pump or cause a fault.
  • Page 15 2 Safety Symbol Meaning Model number General warning sign (Background: yellow; Symbol & outline: black) Caution, read the accompanying documents Defibrillation-proof type CF applied part Class II equipment IP34 Protected against solid foreign objects of 2,5 mm Ø and greater; protected against splashing water Alternating current Direct current...
  • Page 16 2 Safety Symbol Meaning Refer to instruction manual/booklet (Background: blue; symbol: white) Comply with the requirements of Directive 2012/19/EU Waste Electrical & Electronic Equipment Non-ionizing electromagnetic radiation This way up Fragile, handle with care Keep dry Keep away from sunlight Atmospheric pressure limitation Temperature limit Humidity limitation...

  • Page 17: Roduct Specifications

    3     P roduct Specifications Name Ambulatory infusion pump Model / Specifications ELFensor P3, ELFensor P6, ELFensor P9 Dimensions 103 mm (W) × 107 mm (H) × 33 mm (D) Weight About 0.37 kg (battery included) Operating Conditions Ambient temperature: 5°C ~ 40°C...
  • Page 18 − Charging duration: ≤4h when powered off and ≤7h when powered on and at the infusion rate of 5 ml/h ● Powered by four AA batteries (ELFensor P3) − Battery brand: NANFU (model: LR6) − Battery life (continuous operation at room temperature with default settings): ≥168h at the infusion rate of 5 ml/h;...
  • Page 19 Specifications: 50 ml, 100 ml, 150 ml, 300 ml, and 500 ml Specifications Infusion Modes ELFensor P3: PCA Mode, PCS Mode, PCEA Mode, PIEB Mode, and Rate Mode ELFensor P6/P9: PCA Mode, PCS Mode, PCEA Mode, PIEB Mode, Chronological Mode, Rate Mode, Time Mode, Weight...
  • Page 20 3 Product Specifications Alarm Message Infusion End, Infusion End KVO Start, Battery Empty, Patient-side OCCL, Air Bubble In Line, Fluid-side OCCL, Cassette Detached, Infusion Near End, Cass. Unlocked, Reminder Alarm, Standby End, Dose Limit Exceeded, Communication Error, Battery Low, No Battery, No AC Power, PCA Controller Removed, and mechanical fault (ERR211) Date of Manufacture See the product label...

  • Page 21: Roduct Description

    (optional). The product does not include the pump infusion tubing and medication cassette reservoirs. NOTE: The power adapter is provided for ELFensor P6/P9 and optional for ELFensor P3. 4�2 Operating Principle This ambulatory infusion pump is intended to infuse, through positive pressure, a preset volume of drug liquid into the patient's body.

  • Page 22: Schematic Description

    4 Product Description 4�3 Schematic Description No� Item Description Alarm indicator Red: high-priority alarm Yellow: low- or medium-priority alarm Operating When drug is infused at the continuous rate, this indicator flashes indicator in green. Power indicator ● When the pump is powered by using the power adapter and the internal lithium battery is being charged, the power indicator is blue.
  • Page 23 4 Product Description No� Item Description Cassette latch Used to secure the cassette onto the pump and prevent unexpected detachment. Hinge pin Used to secure the medication cassette reservoir. Patient-side Used to detect occlusions on the patient side. occlusion sensor Squeeze Used to squeeze the infusion tubing to realize liquid flow during mechanism...

  • Page 24: Display

    4 Product Description 4�4 Display Information Area Rate 09:23 Morphine Surplus Vol. Rate 95.5 ml Data Area 15.0 Left Time ml/h 06:22:12 Button Area Operation C.Bolus Pause Area Description Information area Displays information such as the interface name, time, Wi-Fi signal, external power supply, battery level, and alarm message.

  • Page 25: Accessories

    Packing list PCA controller NOTE: • Four AA batteries are provided for ELFensor P3. The rechargeable lithium battery is provided for ELFensor P6/P9. • The power adapter is provided for ELFensor P6/P9 and optional for ELFensor P3. • Two types of PCA controller are available: one with a 0.3m cable and one with a 2m cable.

  • Page 26: Nstallation Instructions

    Keep the package and packaging materials for future storage and transport. 5�3 Power Supply The ELFensor P3 ambulatory infusion pump can be powered by four AA batteries or AC power. The ELFensor P6/P9 ambulatory infusion pump can be powered by the internal lithium battery or AC power.

  • Page 27: External Power Supply

    5 Installation Instructions The power adapter can be used as an alternate source of power for the pump and/or to recharge the internal lithium battery. The pump requires that AA batteries or the internal lithium battery are installed as a backup while using the power adapter. Otherwise, when the external power supply is cut off due to a power failure or short circuit, the pump may shut down and fail to trigger alarms, which causes safety risks.
  • Page 28 5 Installation Instructions ● Do not expose the battery to sunlight or temperatures above 60℃. ● Do not use or charge the battery near fire or heat sources. ● Do not use a sharp object to knock or puncture the battery. ●...

  • Page 29: Aa Batteries

    5 Installation Instructions 3. Install the battery compartment cover back by aligning it with the clip and pushing it back in place until you hear a clicking sound. 5�3�3 AA Batteries ● Before AA battery replacement, be sure to stop the running infusion or power off the pump. ●...

  • Page 30: Attaching And Detaching A Medication Cassette Reservoir

    5 Installation Instructions 3. Install the battery compartment cover back by aligning it with the clip and pushing it back in place until you hear a clicking sound. 5�4 Attaching and Detaching a Medication Cassette Reservoir Before you attach a medication cassette reservoir to the pump, ensure that no air bubble exists in the cassette reservoir and the cassette reservoir has no crack or leakage.

  • Page 31: Connecting To The Pole Clamp (Optional)

    5 Installation Instructions The indicator on the PCA controller has the following states: ● Solid green: indicates that the press is valid and a demand dose has started. ● Flashing in green: indicates that the patient now can press the PCA controller or the PCAdose button on the pump to start a demand dose.

  • Page 32: Installing The Pump Onto An Iv Pole

    5 Installation Instructions Slot 5�7 Installing the Pump onto an IV Pole After you connect the pump to the pole clamp, install the pump and pole clamp together onto an IV pole. 1. Rotate the IV pole retaining knob of the pole clamp counterclockwise and insert the IV pole into the pole clamp.

  • Page 33: Putting The Pump Into The Pouch (Optional)

    5 Installation Instructions 5�8 Putting the Pump into the Pouch (Optional) This ambulatory infusion pump can be put into the pouch provided by the manufacturer and then carried by the patient. 1. Put the pump, with the medication cassette reservoir attached, into the pouch. 2. Pull the infusion tubing out of the pouch through the opening. 3.

  • Page 34: Perating Instructions

    LoadingDose mode, Intermittent mode, and Trapezia mode. The default infusion mode is PCA mode. NOTE: For ELFensor P3, only five infusion modes are supported: PCA mode, PIEB mode, PCEA mode, PCS mode, and Rate mode. To select an infusion mode, perform the following steps: 1.
  • Page 35 DemandBolus Enable or disable the setting of a demand bolus. PCEA Mode Infusion Rate ELFensor P3/P6: 0.1 - 500 ml/h ELFensor P9: 0.1 - 800 ml/h Dose Lmt. Enable or disable the setting of an upper limit on the infusion volume within a certain number of hours.

  • Page 36: Selecting A Drug

    6 Operating Instructions 6�4 Selecting a Drug This pump supports the drug selection function. To enable this function, choose Local Settings > Infusion Settings > Common Settings and then turn on Drug Selection. After you select an infusion mode, you can select New Infusion to start configuring a new infusion.
  • Page 37 6 Operating Instructions PCEA stands for Patient Controlled Epidural Analgesia. When the patient feels pain during an infusion, the patient can press the PCAdose button on the pump or the connected PCA controller to administer a preset demand dose of medication to the epidural space to relieve the pain.
  • Page 38 6 Operating Instructions • If the continuous rate is not set to 0, apart from demand doses initiated by the patient, there is a continuous infusion at this rate in the background. • A bolus cannot be started during a loading dose, a demand dose, or a PIEB dose. •...
  • Page 39 VTBI 0.1 - 999.9 ml. The increment is 0.1 ml. Infusion Rate ELFensor P3/P6: 0.1 - 500 ml/h ELFensor P9: 0.1 - 800 ml/h ● Between 0.1 and 99.9 ml/h, the increment is 0.1 ml/h. ● Between 100 and 800 ml/h, the increment is 1 ml/h.
  • Page 40 6 Operating Instructions Parameter Description 0.01 - 5.60 m The increment is 0.01. Dose Rate Unit If you set the calculation method to weight, available dose rate units are X/kg/h, X/kg/min, X/kg/24h, X/h, X/min, and X/24h. If you set the calculation method to BSA, available dose rate units are X/ /h, X/m /min, X/ m /24h, X/h, X/min, and X/24h.
  • Page 41 6 Operating Instructions On the parameter setting interfaces, set the VTBI, LoadingDose, Loading  Rate, and Maintain Rate parameters. The values of the Loading Time and Maintain Time parameters are automatically calculated. Parameter Description VTBI 0.1 - 999.9 ml. The increment is 0.1 ml. LoadingDose 0.1 - 999.9 ml.

  • Page 42: Priming

    6 Operating Instructions Parameter Description VTBI 0.1 - 999.9 ml. The increment is 0.1 ml. Steady Rate ELFensor P6: 0.1 - 500 ml/h ELFensor P9: 0.1 - 800 ml/h ● Between 0.1 and 99.9 ml/h, the increment is 0.1 ml/h. ●...

  • Page 43: Starting The Infusion

    6 Operating Instructions Rate 09:23 Morphine Prime Rate Quit ml/h Edit Param. Start Operation 4. After ensuring that the administration set is disconnected from the patient, tap Yes. The pump starts priming at the default prime rate and stops when the prime volume reaches the preset value or when you tap Stop Prime.

  • Page 44: Starting A Bolus

    2. Set the C. Bolus Rate and C. Bolus VTBI parameters. The value of the C. Bolus Time parameter is automatically calculated. Parameter Description C. Bolus Rate ELFensor P3/P6: 0.1 - 500 ml/h ELFensor P9: 0.1 - 800 ml/h C. Bolus VTBI 0.1 - 50.0 ml 3. Tap OK. The pump starts a bolus.

  • Page 45: Viewing Report

    6 Operating Instructions • The VTBI parameter can be edited only before an infusion is started or when the infusion is paused. The LoadingDose parameter can be edited only before an infusion is started. 6�7�3 Viewing Report During the infusion, you can choose Operation > View Report to view historical infusions and event logs.

  • Page 46: Selecting Adverse Reactions

    6 Operating Instructions 6�7�6 Selecting Adverse Reactions On the infusion running or pause interface, choose Operation > Adverse Reactions. Select one or more adverse reactions and tap OK. 6�7�7 Performing Quick Settings On the infusion running or pause interface, choose Operation > Quick Settings. On the Quick Settings interface, you can change patient information, the brightness and volume levels, alarm settings, and infusion settings.

  • Page 47: Putting The Pump Into The Standby State

    6 Operating Instructions 6�10 Putting the Pump into the Standby State Press the ON/OFF button. On the interface that appears, tap Standby. The screen displays the remaining standby time. You can tap Settings to modify the remaining standby time or tap Quit to exit the standby state. 6�11 Powering off the Pump Press and hold the ON/OFF button and tap Power Off on the interface that appears.

  • Page 48: Enu Settings

    7     M enu Settings Local settings of this ambulatory infusion pump include system settings and infusion settings. These settings are stored in the internal memory of the pump and are not lost in case of power failures. During each startup, the pump automatically loads these settings. When you power on the pump, the pump starts a self-check and then displays the home interface.
  • Page 49 7 Menu Settings NOTE: • Set an appropriate alarm volume based on clinical conditions. If the alarm volume level is set to lower than the ambient noise, the alarm audio may not be heard, which may cause patient hazards. • Alarm settings must be completed by professional technicians authorized by the manufacturer to ensure appropriate priorities for the alarm system.

  • Page 50: Infusion Settings

    7 Menu Settings 7�1�2 Infusion Settings Infusion settings include KVO settings, occlusion settings, bubble settings, common settings, prime settings, and auto sleep. ■  KVO Settings KVO stands for Keep Vein Open. If the KVO function is enabled, after finishing an infusion task that features a preset VTBI, the infusion pump continues to infuse liquid at the preset KVO rate.
  • Page 51 7 Menu Settings • If a high occlusion level is set, the occlusion alarm is triggered only when a relatively high pressure is accumulated in the infusion tubing. Ensure that the infusion tubing is firmly connected to the medication cassette reservoir. •...

  • Page 52: Device Information

    7 Menu Settings ■  Prime Settings Parameter Description Prime Rate Set a prime rate. Valid values: ELFensor P3/P6: 0.1 - 500 ml/h ELFensor P9: 0.1 - 800 ml/h Prime Vol. Set a prime volume. Valid values: 1.0 - 30.0 ml. ■  Auto Sleep Parameter...
  • Page 53 7 Menu Settings Parameter Description WLAN Settings Enable or disable DHCP (Dynamic Host Configuration Protocol). ● If you enable DHCP, network information is obtained automatically. ● If you disable DHCP, you need to configure network information manually. Login Tip Enable or disable the prompt that reminds you to log in to the infusion central monitoring system.

  • Page 54: Manufacturer Maintenance

    7 Menu Settings We recommend that when you use the pump for the first time, you change the password to ensure security. 7�1�5 Manufacturer Maintenance To ensure the stability and precision of the pump, manufacturer maintenance shall be performed by professional technicians of the manufacturer. 7�2 Patient Management On the home interface, tap Patient Mgmt.

  • Page 55: Larms And Faults

    8     A larms and Faults 8�1 Alarm Priorities The infusion pump provides status information about itself and infusion processes. In case of an exception such as a fault, the pump triggers an alarm with text, sound, and light signals. Based on fault severity and threat to safety, alarms are classified into three priorities: low- priority alarms, medium-priority alarms, and high-priority alarms.
  • Page 56 8 Alarms and Faults Alarm Message Alarm Fault Cause Troubleshooting Priority ! Battery Low The battery is running Connect the pump to AC low. power or replace the battery. !!! Battery Empty High The battery is depleted. Connect the pump to AC power or replace the battery.

  • Page 57: System Faults And Troubleshooting

    8 Alarms and Faults Alarm Message Alarm Fault Cause Troubleshooting Priority !! Cass. Unlocked Medium The cassette reservoir Lock the cassette reservoir. is unlocked. !! Communication Medium The network Reconnect the pump to the Error connection failed. network. ! PCA Controller The infusion has Connect the PCA Removed...

  • Page 58: Leaning And Disinfection

    9     C leaning and Disinfection Use the materials and methods described in this chapter to clean and disinfect the ambulatory infusion pump. Use of other materials or methods may damage the pump or shorten its service life. ● If you have any questions about the use of cleaning agents or disinfectants, consult your local distributor.

  • Page 59: Disinfection

    9 Cleaning and Disinfection Cleaning procedure: 1. Immerse a lint free cloth in a neutral or weakly alkaline cleaning agent and then wring out the cloth. 2. Use the lint free cloth to wipe the surfaces of the pump until all contaminants are removed. Be sure to wipe every side and corner of the pump.

  • Page 60: Air Drying And Transport

    9 Cleaning and Disinfection 9�4 Air Drying and Transport ● Do not dry the pump by using a drying machine or similar product. ● Connect the pump to the power supply again after the pump is completely dry. After cleaning and disinfection, place the pump in a shady, cool, and ventilated environment for air drying.

  • Page 61: Aintenance

    10     M aintenance All preventative and corrective maintenance and all such activities should be performed by Qualified Service Personnel only, with reference to the Service Manual. 10�1 Regular Maintenance To ensure safe use and lengthen the service life of the infusion pump, perform regular maintenance on the infusion pump as described in the following table or perform maintenance when needed.

  • Page 62: Alarm Check

    10 Maintenance 10�1�4 Alarm Check ● During startup, the infusion pump automatically checks the alarm system. You can check whether the alarm system works properly based on the following description. If an exception is found, stop using the pump and contact your local distributor or the manufacturer for repair.

  • Page 63: Electrical Safety Test

    10 Maintenance ● Aging is an inherent characteristic of battery. To ensure safe operation of the pump, contact your local distributor for battery replacement after the internal battery has been used for two years. ● Before battery replacement, ensure that the pump is powered off and disconnected from the external power supply.
  • Page 64 4. Remove the PCA controller. Plug the connector of the PCA controller out of the PCA port of the pump. 5. Take the AA batteries out of the pump (only applicable to ELFensor P3). 6. Pack the pump, batteries, and accessories with dedicated medical waste bags and mark them properly.

  • Page 65: Nfusion Characteristics

    ■  Accuracy test conditions (chapter 201.12.1.103) ● Temperature: 20.5~21.7℃ ● Relative humidity: 59.1~62.7% ● Medication cassette reservoir: MEDCAPTAIN LIFE SCIENCE CO., LTD (500ml); 1 pc ● Infusion pump: 1 pc ● Sampling interval: 15 min ● Test period: 2940 min ● Test liquid: ISO 3696:1987 Class III water...
  • Page 66 11 Infusion Characteristics ■  Accuracy test results Start-up graph @ 1 ml/h Trumpet curve @ 1 ml/h User Manual...
  • Page 67 Accuracy test conditions (chapter 201.12.1.104) ● Temperature: 22.5~24.1℃ ● Relative humidity: 57.5~70.0% ● Medication cassette reservoir: MEDCAPTAIN LIFE SCIENCE CO., LTD (500ml); 1 pc ● Infusion pump: 1 pc ● Infusion mode: intermittent mode ● Preset infusion rate: 5ml/h (Actual infusion rate during sampling intervals: 2 ml/h) ●...

  • Page 68: Occlusion Response Characteristics

    The following test is performed by using the method described in chapter 201.12.4.4.104 of IEC 60601-2-24:2012. For details, see the previous chapter. ■  Occlusion test conditions ● Temperature: 21.3~22.0℃ ● Relative humidity: 61.5~62.2% ● Medication cassette reservoir: MEDCAPTAIN LIFE SCIENCE CO., LTD (150ml); 1 pc User Manual...
  • Page 69 11 Infusion Characteristics ● Infusion pump: 1 pc ● Length of the infusion tubing: 1m ■  Occlusion test results Table  11-1  Occlusion Level, Alarm Delay, and Unintended Bolus Volume Infusion Rate Occlusion Pressure (mmHg) Occlusion Alarm Time (h:m:s) 0.1 ml/h 03:00:00 1500 06:00:00 1 ml/h 00:18:00 1500 00:36:00 Infusion Rate Occlusion Pressure  Occlusion Alarm  Unintended Bolus Volume  (mmHg) Time (h:m:s) (ml) 5 ml/h 00:04:00 1500...

  • Page 70: Appendix A Electromagnetic Compatibility (Emc)

    ● The ELFensor P3/P6/P9 ambulatory infusion pump complies with the EMC standards IEC 60601-1-2:2020 and IEC 60601-2-24:2012. ● Users must install and use the ELFensor P3/P6/P9 ambulatory infusion pump based on the EMC information provided in the accompanying document. ● Portable and mobile RF (Radio-Frequency) communication devices may affect the performance of the ELFensor P3/P6/P9 ambulatory infusion pump.
  • Page 71 Guidance and manufacturer’s declaration – electromagnetic emissions The ELFensor P3/P6/P9 ambulatory infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user of the ELFensor P3/ P6/P9 ambulatory infusion pump should ensure that it is used in such an environment.
  • Page 72 135 º, 180 º, and voltage environment. If the user 270 º and 315 º ; 225 º, 270 º variations on of the ELFensor P3/P6/ 0% 1 cycle and 315 º ; power supply P9 ambulatory infusion 0% 1 cycle...
  • Page 73 Guidance and manufacturer’s declaration – electromagnetic immunity The ELFensor P3/P6/P9 ambulatory infusion pump is intended for use in the electromagnetic environment specified below. The customer or the user of the ELFensor P3/ P6/P9 ambulatory infusion pump should ensure that it is used in such an environment.
  • Page 74 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ELFensor P3/P6/ P9 ambulatory infusion pump is used exceeds the applicable RF compliance level above, the ELFensor P3/P6/P9 ambulatory infusion pump should be observed to verify normal operation.
  • Page 75 Appendix A Electromagnetic Compatibility (EMC) For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

  • Page 76: Appendix B Default Factory Settings

    Appendix  B  Default Factory Settings This appendix lists some default factory settings of the ELFensor P3/P6/P9 ambulatory infusion pump. You can restore the infusion pump to default factory settings if necessary. Parameter Default Factory Setting Infusion Mode PCA mode Prime Vol. 5 ml C. Bolus VTBI...

  • Page 77: Appendix C Minimum It Requirements

    Appendix  C  Minimum IT Requirements ■  Hardware 2.4GHz or 5GHz wireless network ■  IT networks characteristics ● Support the TCP/IP communication protocol. ● Support the IPv4 protocol. ■  IT security measures ● Always deploy the wireless network according to local wireless regulations. ● Data communication for all network functions must be performed within the closed network or within the virtually isolated network provided by the hospital.
  • Page 78 Appendix  D  Parameter Units Parameter Unit Drug amount ng, ug, mg, g, unit, kunit, munit, mIU, IU, kIU, EU, mmol, mol, kcal, and mEq Concentration ng/ml, μg/ml, mg/ml, g/ml, unit/ml, kunit/ml, munit/ml, mIU/ml, IU/ ml, kIU/ml, EU/ml, mmol/ml, mol/ml, kcal/ml, and mEq/ml Dose rate X/min, X/h, X/kg/min, X/kg/h, X/24h, X/kg/24h, X/m /min, X/m...

This manual is also suitable for:

Elfensor p6Elfensor p9

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