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B - 1

B

EMC and Radio Regulatory Compliance

B.1

EMC

The device meets the requirements of IEC 60601-1-2: 2014.

WARNING

•

Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this device could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
device and result in improper operation.

•

Use of this device adjacent to or stacked with other device should be avoided
because it could result in improper operation. If such use is necessary, this
device and the other device should be observed to verify that they are
operating normally.

•

Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the this device, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this device
could result.

•

The non-ME EQUIPMENT (e.g. ITE) that is a part of an ME SYSTEM may be
disrupted by the electromagnetic interference of nearby equipment. It may
be necessary to take mitigation measures, such as re-orienting or relocating
the non-ME EQUIPMENT or shielding the location.

•

This device is intended for use in professional healthcare facility
environment only. If it is used in special environment, such as magnetic
resonance imaging environment, the equipment/system may be disrupted
by the operation of nearby equipment.

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Содержание BeneFusion eSP Vet

Страница 1: ...BeneFusion eSP Vet Veterinary Syringe Pump Operator s Manual ...

Страница 2: ......

Страница 3: ...I Copyright 2021 Shenzhen Mindray Animal Medical Technology Co LTD All rights reserved Release date 2021 04 Revision 1 0 ...

Страница 4: ... is the trademark of SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD in China and other countries All other trademarks that appear in this manual are used only for informational or editorial purposes They are the property of their respective owners Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice All information contained in this manual i...

Страница 5: ...all not extend to Malfunction or damage caused by improper use or man made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people Malfunction of the instrument or part whose serial number is not le...

Страница 6: ...gral part of the product It should always be kept close to the equipment so that it can be obtained conveniently when needed Intended Audience This manual is geared for clinical professionals who are expected to have a working knowledge of medical procedures practices and terminology as required for monitoring of critically ill patients Illustrations All illustrations in this manual serve as examp...

Страница 7: ...5 Using the On Screen Keyboard 2 9 3 Equipment Preparation 3 1 3 1 Equipment Preparation Safety Information 3 1 3 2 Environmental Requirements 3 2 3 3 Installation 3 2 3 3 1 Pole Clamp Installation 3 2 3 3 2 Stack Rack Installation 3 2 3 4 Setting Up the Equipment 3 3 3 4 1 Connecting the AC Mains 3 3 3 4 2 Charging the Battery 3 3 3 4 3 Adjusting the Screen Brightness 3 4 3 4 4 Setting the Date a...

Страница 8: ...anceling the Relay 5 2 5 3 Performing Day s Prescription 5 3 5 4 Configuring Pumps in Batches through the Dock 5 3 6 Alarms 6 1 6 1 Alarm Safety Information 6 1 6 2 Understanding the Alarms 6 1 6 2 1 Alarm Priorities 6 1 6 2 2 Alarm Indicators 6 1 6 2 3 Alarm Screen 6 2 6 3 Resetting Alarms 6 3 6 4 Pausing Alarm Sound 6 3 6 5 Setting the Alarm Sound 6 4 6 5 1 Setting the Alarm Volume 6 4 6 5 2 Set...

Страница 9: ...1 Password Protected Settings 11 1 11 1 Accessing the User Maintenance Menu 11 1 11 2 The Device Management Settings 11 1 11 3 The Patient Information Settings 11 1 11 4 System Calibration 11 2 11 5 Network Setup 11 2 11 5 1 The WLAN Settings 11 2 11 5 2 The WLAN IP Settings 11 2 11 5 3 The Central Station Setup 11 3 11 5 4 The Device Discover Settings 11 3 11 6 The Brand Management 11 3 11 7 The ...

Страница 10: ...g Version Information 12 6 12 6 Checking the History Record 12 6 12 7 Exporting the History Record 12 6 12 8 Disposing of the Equipment 12 7 13 Care and Cleaning 13 1 13 1 Care and Cleaning Safety Information 13 1 13 2 Cleaning the Equipment 13 2 13 3 Disinfecting the Equipment 13 2 13 4 Cleaning the Pole Clamp and Stack Rack 13 5 13 5 Disinfecting the Pole Clamp and Stack Rack 13 5 13 6 Steriliza...

Страница 11: ... 4 A 8 Recommended Syringes A 6 A 9 Occlusion Alarm Delay and Bolus Volume A 7 A 10 Infusion Accuracy Graphs A 8 A 10 1 Infusion Accuracy at 1 ml h A 8 A 10 2 Infusion Accuracy at 5ml h A 9 B EMC and Radio Regulatory Compliance B 1 B 1 EMC B 1 B 2 Radio Regulatory Compliance B 7 C Abbreviations C 1 D Declaration of Conformity D 1 ...

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Страница 13: ...c shock the equipment must only be connected to mains power with protective earth If a protective earth conductor is not provided operate it on battery power if possible To avoid explosion hazard do not use the equipment in the presence of oxygen rich atmospheres flammable anesthetics or other flammable agents The equipment is not intended to be used within the Magnetic Resonance MR environment Do...

Страница 14: ... Cautions CAUTION When several infusion lines are connected to the same vascular access there may be back flow or prolonged response time of occlusion alarm Therefore use check valve at the line end or follow local hospitals instructions while in connection with other infusion system Ensure that the equipment is supplied with continuous electric power during work Sudden power failure may cause dat...

Страница 15: ...started This manual describes all features and options Your equipment may not have all of them 1 2 Equipment Symbols Some symbols may not appear on your equipment Refer to instruction manual booklet Caution Alternating current Input output Battery USB connector Both direct and alternating current Direct current Date of manufacture Manufacturer IP33 Protected against solid foreign objects with a di...

Страница 16: ... Fragile handle with care STACKING LIMIT BY NUMBER CE mark Serial number General warning sign Stop Stand by Non ionizing electromagnetic radiation Temperature limitations Dispose of in accordance to your country s requirements ...

Страница 17: ...usion fluids through clinically accepted routes of administration including intravenous and intra arterial routes WARNING This pump is intended for use only by clinical professionals or under their guidance It must only be used by persons who have received adequate training in its use Anyone unauthorized or untrained must not perform any operation on it 2 2 Applied Part The applied part of the equ...

Страница 18: ...ernal power LED On when external power supply is connected Off when external power supply is not connected 7 Plunger grippers Secures the plunger to the driver head 8 Driver head Presses the plunger of the syringe 9 Alarm light When a physiological alarm or technical alarm occurs this lamp lights and flashes corresponding with the alarm priority High priority alarms the lamp quickly flashes red Lo...

Страница 19: ...ecures the extension set 2 Door Open the door to load or unload the syringe 3 Barrel Clamp Secures the barrel and the barrel flange to the pump and identifies the syringe barrel size 4 Flange Retainer Secures the barrel flange to the pump ...

Страница 20: ...ects the equipment to the hospital s nurse call system through the nurse call cable Uses as a DC power input connector when the equipment is connected to the dock Uses as a RS232 connector for connecting the external devices 3 USB connector Connects the USB device 4 AC power input connector Connects the AC power cord ...

Страница 21: ... 1 Product label 2 Placement area for stacking pumps This area is for stacking the pumps with the handle 3 Placement area for pole clamp This area is for mounting the pump to a pole clamp 1 2 3 4 5 6 1 System status information area Displays the alarm information infusion mode syringe brand or bed number 2 Infusion status area Displays the drug name and major infusion parameters ...

Страница 22: ...ressure is near the threshold for the infusion Red Pressure is beyond the threshold for the infusion 6 Key area Displays keys For more information see 2 4 3 Operation Keys Symbol Description Symbol Description Audible alarm tones are paused Alarms are acknowledged and the alarm is reset Alarms are acknowledged and the reminder sound is given Night mode Wireless network is connected The solid part ...

Страница 23: ...charge and needs to be charged immediately Otherwise the equipment will automatically shut down No battery is installed Battery fault battery communication fault or battery charging fault Contact service personnel for help Symbol Description Symbol Description 1 2 3 1 Menu heading 2 Submenu tabs or menu options 3 Operation buttons Symbol Label Function Symbol Label Function AudioPause Pauses alarm...

Страница 24: ...ted NOTE Wipe off any water on the touchscreen in case of rain or water spray Standby Enters Standby Purge Initiate a purge Volume Enters the Volume menu Menu Enters the Menu Exit Returns to the main screen Bolus Initiate a Bolus infusion Start Starts an infusion Stop Pause an infusion Back Returns to the previous screen or the parameter setup screen Home Returns to the main screen Setup Enters th...

Страница 25: ...ter information Enter the information by selecting one character after another Select the Backspace key to delete single characters Select the Caps Lock key to switch uppercase letters and lowercase letters Select the Enter key to confirm the entry and close the on screen keyboard ...

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Страница 27: ...ystems standard Any personnel who connect devices to the equipment s signal input output port are responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601 1 If you have any questions please contact Mindray Animal Medical If it is not evident from the equipment specifications whether a particular combination with other devices...

Страница 28: ...em before the condensation evaporates CAUTION Make sure that the equipment operating environment meets the specific requirements Otherwise unexpected consequences e g damage to the equipment could result 3 3 Installation 3 3 1 Pole Clamp Installation The pole clamp secures the pump to either a horizontal or vertical bar of the medical supply unit or IV pole For detailed information on how to insta...

Страница 29: ...he power cord to a wall AC outlet 3 Check that the external power supply indicator is on The external power LED lies at the right side of the display When the AC mains is not connected the external power LED is off When AC mains is connected the external power LED is illuminated in green WARNING Always use the accompanying power cord delivered with the pump Before connecting the equipment to the A...

Страница 30: ...t Menu select System Options 2 Set the Brightness and Brightness On Battery The pump automatically adjust the screen brightness according to the set brightness when the pump is switching between the external power and battery power 3 4 4 Setting the Date and Time To set the system time follow this procedure 1 Swipe the touchscreen from top down select Menu select User Maintenance input the require...

Страница 31: ...cting the AC Mains Press the power switch to turn on the pump The pump automatically performs a self test at startup Check that the alarm tone is heard and the alarm lamp illuminates one after the other in red and yellow This indicates that the visible and audible alarm indicators function correctly The loading guide screen displays If required select Exit to enter the infusion parameters setting ...

Страница 32: ...a clear view of the pump interface The equipment uses a mains plug as isolation means to the mains power Do not locate the equipment in a place difficult to operate the mains plug 4 3 Loading the Syringe 1 Pull the door 1 open and pull down the syringe clamp 2 2 Place the syringe into the syringe slot 3 ensuring that the barrel flange 4 is in the space between the pump and the flange retainer 5 2 ...

Страница 33: ...ger 9 end and the plunger grip pers 10 automatically squeezes the plunger flange 11 4 Place the extension line into the extension set holder 12 5 Close the pump door If the syringe is properly loaded the veterinary syringe pump automatically identifies the syringe size and displays the volume in the brand selection area 8 9 10 11 6 7 12 ...

Страница 34: ...ned close to the patients heart level As the volume of fluid contained in the extension set and retained in the syringe at the end of infusion will not be infused allow for this dead space volume when initially loading the syringe Single use accessories are not designed to be reused Reuse may cause a risk of contamination and affect the measurement accuracy CAUTION Secure the extension set using t...

Страница 35: ... patient If the extension set and the syringe are not purged before being loaded into the pump proceed as follows to purge the line 1 Ensure that the pump is disconnected from the patient 2 Swipe the touchscreen from top down and select 3 Select to start purging 4 If required set the Purge Rate 5 When purging is complete select to stop purging NOTE If required set the purge rate after the purge st...

Страница 36: ...lus volume in the popup dialog 3 Select to start a bolus infusion The pump continues the infusion when the configured bolus volume has been infused If required select to stop the bolus infusion NOTE If required adjust the bolus rate in the BolusRate area during an automatic bolus infusion 4 6 3 Manual Bolus Infusion To perform a manual bolus infusion follow this procedure 1 Select from the main sc...

Страница 37: ...the popup dialogs To change other infusion parameters follow this procedure 1 Press to pause the infusion 2 Select the desired parameter area and reconfigure parameters as per the prescriber s order 3 Select OK to confirm the changing 4 Press again to resume the infusion 4 8 Pausing the Infusion Press to temporarily stops a running infusion Press again to restart the infusion after the infusion so...

Страница 38: ...reen select to stop the infusion 2 Clamp the extension set 3 Disconnect the patient from the extension set 4 Open the door 1 5 Remove the extension set from the extension set holder 2 6 Pull down the syringe clamp 3 and remove the syringe from the pump 4 7 Proceed the next operation as needed Continue the therapy see 4 3 Loading the Syringe and 4 4 Starting Infusion Enter the standby mode see 4 12...

Страница 39: ...t be cleared when an infusion is running 1 2 3 4 5 1 Past 24h Total view the total infused volume in the past 24 hours The display range is 0 ml to 99999 99 ml Select Clear to clear the infused volume 2 View the total infused volume in the configured time period Configure the time period before viewing the total infused volume in the configured time period 3 View the recent total infused volume Co...

Страница 40: ...it the standby mode select 4 13 Turning Off the Pump Before turning off the pump perform the following check 1 The infusion is completed 2 The patient is disconnected from the pump 3 The syringe is removed from the pump To turn off the pump press and hold the power switch and select Turn Off CAUTION Press and hold the power switch for no less than 10 seconds to forcibly shut down the pump if it co...

Страница 41: ...mp in the Dock To secure the pump in the Dock firmly push the pump until you hear that the clip engages the pump bay To unlock and remove the pump hold the pump then turn the unlocking knob clockwise to the vertical position and slide the pump out of the bay CAUTION The alarm sound from the pump is enabled when the pump is secured in the BeneFusion eDS Vet Veterinary Infusion Supervision System Do...

Страница 42: ...from top down and select Relay 3 Select one of the following options Customized Relay The relay infusion runs in a preset order and completes when the last relay pump finishes the infusion Circular Relay The relay infusion runs in a preset order and the first pump continues to infuse when the last relay pump completes the infusion 4 From the desired pumps select Yes in the dialog 5 Select the sequ...

Страница 43: ... the system is in proper network connection To perform the prescription follow this procedure 1 Swipe the touchscreen from top down select Menu select Day s Prescription 2 Select the desired prescription and select OK 3 Set infusion parameters in the main screen 4 Select to start the infusion 5 4 Configuring Pumps in Batches through the Dock When pumps are connected to the BeneFusion eDS Vet Veter...

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Страница 45: ... not When the alarm sound is paused observe the patient frequently Do not rely exclusively on the audible alarm system during an infusion Adjustment of alarm volume to a low level may result in a hazard to the patient Always make sure that the audio alarm volume level is adequate in your care environment Always keep the patient under close surveillance Fully evaluate the risk before changing the a...

Страница 46: ...3 Alarm Screen When an alarm occurs the alarm screen is displayed to help you identify the problem NOTE The alarm screen always displays the alarm of the highest priority Alarm priority Alarm lamp color Alarm lamp flashing frequency Alarm sound interval Alarm message Alarm priority indicator Duty Cycle High priority alarm Red 2 0 0 6 Hz 5s 2s White text or symbol inside a red box 20 to 60 low prio...

Страница 47: ...llowing ways Select in the alarm screen Swipe the touchscreen from top down and select The audio pause state has the following features Except for the Battery Depleted alarm the sound of all alarms are silenced for two minutes The audio pause symbol is displayed in the system information area If a new alarm is triggered during the audio pause state the sound of the new alarm will also be silenced ...

Страница 48: ...e call system with the equipment s multi function connector Alarms are indicated on the nurse call device only when the following conditions are met The nurse call system is enabled A user defined alarm occurs NOTE Do not rely exclusively on the nurse call system for alarm notification Remember that the most reliable alarm notification combines audible and visual alarm indications with the patient...

Страница 49: ...n High An occlusion occurred and the preset pressure limit is exceeded Check that tubing is not kink or damaged Check the pressure limit setting Increase the limit if necessary Syringe Empty High No fluid is left in the syringe Press to clear the alarm End the infusion or replace the syringe Syringe Disengaged High The syringe is disengaged Reload the syringe No Syringe High The syringe is not loa...

Страница 50: ...ps have completed the infusions yet the downstream pumps are not ready for infusion Check the connection between the pump and the Dock Check that the downstream pumps are properly configured for infusion System Error High The pump system faults such as storage error hardware fault etc Stop using the pump and contact your service personnel KVO Running Low The infusion is completed and the pump cont...

Страница 51: ...e alarm persists contact your service personnel System Time Error Low The real time clock RTC reset or RTC fault Re set the system time See 3 4 4 Setting the Date and Time If the alarm persists contact your service personnel Relay Invalid Soon Low In the relay state the upstream pumps have almost completed the infusions yet the downstream pumps are not ready for infusion Check that the downstream ...

Страница 52: ...on and gives an Occlusion alarm when the pressure exceeds the set limit Occlusion pressure should be configured according to patient needs To set the occlusion pressure follow this procedure 1 Swipe the touchscreen from top down select Menu select General Option select OcclusionPressure 2 Select the desired pressure The pump restarts the infusion when the pressure that caused the alarm is reduced ...

Страница 53: ...agement See 10 Managing Patient Discharge Patient See 10 Managing Patient Day s Prescription See 5 3 Performing Day s Prescription User Maintenance See 11 Password Protected Settings Dock Setup See 5 4 Configuring Pumps in Batches through the Dock Menu Item Default Range Function Current Pressure Displays the current line pressure OcclusionPres sure 450mmHg See A 7 Infusion Specifications Set the ...

Страница 54: ...ot infusing Lock Time in Infusion 15s Off 15s 30s 1min 2min 3min 4min 5min Set for how long the touchscreen automatically locks since the pump is last operated while the pump is infusing The switch is turned off the touchscreen does not automatically lock while the pump is infusing BolusRate Maximum supported rate of syringes or 1200ml h whichever is smaller See A 7 Infusion Specifications Set the...

Страница 55: ...mode The checked infusion mode will be displayed in the infusion mode list of the infusion status area Note Rate Mode and the checked infusion mode in the infusion status area cannot be unchecked Menu Item Default Range Function Menu Item Default Function Sound Volume 6 Set the sound volume The set range is 1 to 8 Brightness 4 Set the screen brightness The set range is 1 to 8 Brightness On Battery...

Страница 56: ...ed off The night mode is not available for the pump Start Time 18 00 Set the start time and end time of the night mode End Time 7 00 Sound Volume 2 Set the system volume and screen brightness during night mode Brightness 2 Nurse Call Switch Off Set the nurse call switch signal type trigger type and alarm level Signal Type Pulse Trigger Type NORM Open Alarm Level High Version Information View the s...

Страница 57: ...te mode and time mode the IV drug therapy continues to infuse at a set rate Rate mode and time mode offers three parameters rate time and VTBI When two of these parameters are entered the third is calculated NOTE The above diagram is also applicable for Dose Mode Micro infusion Mode and Dose Time Mode When infusing in the rate mode and time mode you must set rate but time and VTBI settings are opt...

Страница 58: ...the corresponding unit of Drug Amt Dose Rate or Conc and reconfigure in the popup dialog NOTE Rate and time can only be obtained by calculation They are not available for manual input In the dose mode the supported dose rate units are X kg min X kg h and X kg 24h in which X represents ng ug mg g mU U kU EU mmol mol mcal cal kcal and mEq Some departments may use fixed drug amounts diluent volumes o...

Страница 59: ...s NOTE Rate setting is necessary for an infusion while time and VTBI are optional in the micro infusion mode 8 5 Sequential Mode In sequential mode you can set several parameter groups Each group defines a set of parameters rate time and VTBI The pump infuses at the set sequence 8 5 1 Adding Deleting Sequences You can add up to eleven sequences in the sequential mode To add or delete a sequence fo...

Страница 60: ...the infusion and select the desired parameter area to make the change To change parameters of other sequences follow this procedure 1 Press to pause the infusion 2 Select 3 Select the desired parameter area to make the change 8 6 Intermittent Mode In the intermittent mode intermittent infusion and maintenance are performed alternately and circularly Intermittent stage the pump runs the high rate i...

Страница 61: ... infusion rate decreases until the set VTBI is completed NOTE The Steady Rate can only be obtained by calculation It is not available for manual input Up Time and Down Time are optional parameters The pump runs an infusion at the steady rate if they are not set 8 8 Dose Time Mode The dose time mode allows the clinician to specify the drug amount diluent volume or concentration The dose mode is typ...

Страница 62: ...ting an infusion or when the infusion is paused To do so select the corresponding unit of Drug Amt Dose Rate or Conc and reconfigure in the popup dialog NOTE In the dose time mode the supported dose rate units are X min X h and X 24h in which X represents ng ug mg g mU U kU EU mmol mol mcal cal kcal and mEq Rate and time can only be obtained by calculation They are not available for manual input ...

Страница 63: ...ing features Saving at least 5000 drug names At least 30 colors are available for drug marking Supporting at least 30 drug categories Predefining drugs concentrations occlusion pressures KVO rate bolus volume limit CAUTION The drug library and the drug info library should be created by professionals Checked that the drug and parameter settings are suitable for the care area before use 9 1 Importin...

Страница 64: ...e pump gives prompts 9 2 1 Hard Limits If the set rate dose rate or bolus rate exceeds the lower or upper hard limit configured in the drug library the setting will be rejected Reconfigure the parameter as needed 9 2 2 Soft Limits If the set rate dose rate or bolus rate exceeds the lower or upper soft limit configured in the drug library you can choose to accept or reject the setting Accept the cu...

Страница 65: ...select Menu select Discharge Patient 2 Select Accept WARNING Always discharge the previous patient before starting an infusion Failure to do so can lead to data being attributed to the wrong patient 10 2 Editing Patient Information Edit patient information after a patient has been admitted or when patient information is incomplete or when you want to change patient information To edit patient info...

Страница 66: ...tient 10 4 Importing Patient Information To import the patient information from the USB drive follow this procedure 1 Connect the USB drive to the USB connector 2 Swipe the touchscreen from top down select Menu select Patient Manage ment select Import Patient Information 3 Select OK ...

Страница 67: ...passwords used at your facility 11 1 Accessing the User Maintenance Menu To access the User Maintenance menu follow this procedure 1 Swipe the touchscreen from top down select Menu select User Maintenance input the required password select 2 Select desired tab 11 2 The Device Management Settings 11 3 The Patient Information Settings Menu Item Default Setting Function Facility Inputs the facility t...

Страница 68: ...ation as per the recommended frequency in 12 2 Maintenance and Testing Schedule Data Review Reviews the calibration data Menu Item Default Setting Function SSID Password Security Open Selects the security method WLAN Setup WLAN Band 2 4GHz Sets the WLAN band Menu Item Default Setting Function DHCP Switch On Selects whether to enable the function of automatically getting the IP address IP Address 0...

Страница 69: ...Multicast Address 225 0 0 8 Menu Item Default Setting Function Common Brand Checks or unchecks the brand and select Confirm The checked brand will be displayed in the brand list Add Brand Adds a brand by this procedure input the brand name select a type Regular or Light sensitive select the syringe volume select Confirm The added brand is displayed in the Common Brand menu Delete Brand Selects the...

Страница 70: ...effective after the pump has been restarted Menu Item Default Setting Function 0 01 ml h Off If this switch is turned on 0 01 ml h is available for the Rate setting 50 mmHg Off If this switch is turned on 50 mmHg is available for the Bubble Size setting 1ml Syringe Off If this switch is turned on the pump can recognize the 1ml syringe Menu Item Default Setting Function Pressure Unit mmHg Sets the ...

Страница 71: ...CMS eGW Disconnected Alarm Off Sets whether the disconnection alarm will be triggered when the pump is disconnected from the CMS or eGateway Menu Item Default Setting Function Bolus Volume Unit ml Sets the unit of bolus volume Menu Item Default Setting Function Auto Maximum volume of syringe Sets the upper limit of the auto bolus volume setting If the set bolus volume exceeds the limit the pump pr...

Страница 72: ...ets the parameter memory switch If this switch is turned on the pump can automatically reload the infusion mode and other infusion parameters when restarted if the same drug has been selected Menu Item Default Setting Function Loading Guide On Sets whether enter the loading guide screen when the syringe is not loaded Menu Item Default Setting Function Brand Selection On Sets whether the brand list...

Страница 73: ...ng the User Maintenance menu Menu Item Default Setting Function Select Config file Imports configuration file drug library or brand library by following this procedure connect the USB drive with the configuration file drug library or brand library to the pump s USB connector select Import and Export select the file as needed select Import Select Drug Library Select Brand Library Import Export Conf...

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Страница 75: ...ication of this equipment is allowed This equipment contains no user serviceable parts The safety checks or maintenance involving any disassembly of the equipment should be performed by professional service personnel Otherwise undue equipment failure and possible health hazards could result The service personnel must be properly qualified and thoroughly familiar with the operation of the equipment...

Страница 76: ... Once every two years When you suspect that the occlusion alarm is abnormal When you suspect that the rate is abnormal The syringe is not properly recognized The Syringe Empty alarm is not properly presented Safety Tests Electrical safety tests Once every two years or if required When the power board is repaired or replaced When the main board is replaced When the equipment drops to the ground Oth...

Страница 77: ...ng items for the power on test The equipment powers on properly The alarm system works properly The equipment displays properly 12 3 3 Checking the Battery See steps 1 to 6 of 12 4 4 Conditioning the Battery to check battery performance The operating time of the battery reflects their performance directly If the operating time of a battery is noticeably shorter than that stated in the specificatio...

Страница 78: ...y cause serious damage to your equipment from battery overheating Do not open the battery heat the battery above 60 C incinerate battery or short battery terminals They may ignite explode leak or heat up causing personal injury CAUTION Remove the battery if it will not be used for an extended period of time NOTE Storing the battery at high temperature for an extended period of time will significan...

Страница 79: ...battery if required 12 4 4 Conditioning the Battery The service life of a battery depends on how frequent it is used When properly used the lithium ion battery has a service life of approximately two years If improperly used its service life can be shorten We recommend replacing the battery every two years The performance of the battery deteriorates over time You should condition the battery every...

Страница 80: ...rd menu shows the history of pump activities including the infusions alarms calibrations maintenance configurations and other operations To access the History Record menu follow this procedure 1 Swipe the touchscreen from top down select Menu select System Options 2 Select History Record NOTE A total loss of power has no impact on the history records stored Alarms are saved as events and will rema...

Страница 81: ... is ten years Dispose of the equipment when its service life is reached Follow local regulations regarding the disposal of such product WARNING For disposal of parts batteries packaging materials and accessories where not otherwise specified follow local regulations regarding disposal of hospital waste ...

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Страница 83: ...demiologist Be sure to turn off the system and disconnect all power cables before cleaning the equipment The responsible hospital or institution shall carry out all cleaning and disinfection procedures specified in this chapter CAUTION Turn off the equipment and remove the power cord from the equipment before cleaning and disinfecting Never immerse any part of the equipment or accessories in liqui...

Страница 84: ... and metal parts 5 Dry the surface with a clean cloth Allow the equipment air dry in a ventilated and cool place CAUTION Any contact of cleaners or disinfectants with connectors or metal parts may cause corrosion 13 3 Disinfecting the Equipment Disinfect the equipment as required in your hospital s servicing schedule Cleaning the equipment before disinfecting is recommended Always dilute and use d...

Страница 85: ... Sani Cloth Plus Germicidal Disposable Cloth Wipes PDI Inc PDI Super Sani Cloth Germicidal Disposable Wipe Wipes PDI Inc VIRAGUARD Hospital Surface Disinfectant Towelettle Wipes VERIDIEN corporation Virex II 256 1 256 Liquid Diversey Inc Virex TB Liquid spray Diversey Inc JIAN ZHI SU Disinfectant Tablets Tablet Beijing ChangJiangMai Medical Science Technology Co Ltd JIAN ZHI SU Surface Disinfectan...

Страница 86: ...faces 196ppm Liquid Tristel solutions Limited Surfanios Premium 0 25 Liquid ANIOS LABORATORIES Surfa safe Liquid spray ANIOS LABORATORIES Wip Anios premium Wipes ANIOS LABORATORIES Aniosurf ND premium 0 25 Liquid ANIOS LABORATORIES Mikrobac Tissues Wipes BODE Chemie GmbH Cleanisept Wipes Wipes Dr Schumacher GmbH mikrozid PAA Wipes Wipes Schülke Mayr GmbH mikrozid Sensitive Wipes Wipes Schülke Mayr...

Страница 87: ... be disinfected only when necessary as determined by your hospital s policy Cleaning the accessories before disinfecting is recommended Hydrogen peroxide 3 Liquid Rely On Virkon High Level surface Disinfectant 1 Powder Antec International Ltd 1 Propanol 50 Liquid Descosept forte Liquid Dr Schumacher GmbH Descosept AF Liquid Dr Schumacher GmbH Dismozon plus 0 4 Powder BODE Chemie GmbH mikrozid AF W...

Страница 88: ...ended may have the following impact Product discoloration Metal part corrosion Brittle and breaking wires connectors and equipment housing Reduced cable and leadwire life Overall system performance degradation Equipment malfunction or failure Perform Classic Concentrate OXY 0 5 Powder Schülke Mayr GmbH Dismozon plus 0 4 Powder BODE Chemie GmbH Descosept AF Liquid Dr Schumacher GmbH Descosept forte...

Страница 89: ...cessory performance is degraded due to aging or environmental conditions contact your service personnel Check the accessories and their packages for any sign of damage Do not use them if any damage is detected Use the accessories before the expiry date if their expiry date is indicated PN Description 0020 20 12522 Power cord 10A 250V 2 5m International 009 001075 00 Power cord 250V 10A 3m Brazil 0...

Страница 90: ...14 2 115 070532 00 Stack rack 115 074974 00 Quick install pole clamp 115 074975 00 Standard pole clamp 045 001434 00 Multi pump bracket PN Description ...

Страница 91: ...ment energized from an internal electrical power source Degree of protection against electrical shock Defibrillation proof type CF applied part direct cardiac application Mode of operation Continuous Degree of protection against harmful ingress of water IP33 Degree of safety of application in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide The equipment is not...

Страница 92: ...t a rate of 5ml h under standard operating conditions Charge time 20 hours for smart and normal battery operating at a rate of 5 ml h charged by the Dock 6 hours for smart battery and 5 hours for normal battery the pump is off and charged by the AC power supply Shutdown delay At least 30 minutes after first low battery alarm operating at a rate of 5ml h under standard operating conditions Operatin...

Страница 93: ... LED 1 green Speaker Gives alarm tones sound pressure 50 to 65 dB Supports multi level tone modulation Alarm tones comply with IEC 60601 1 8 Power input connector 1 Multifunctional connector 1 USB connector 1 Multifunctional connector Standard Meets the requirements of IEC 60601 1 for short circuit protection and leakage current Nurse Call Signal Driving mode Relay drive Electric specification 60W...

Страница 94: ... data through the wireless access point AP Data security Standard WPA PSK and WPA2 PSK Encryption TKIP and AES System capacity Number of the pumps supported by a single AP 16 Data transmission delay between the pump and the CMS Total data transmission delay time between the pump and the CMS is 8s Interruption number and time between the pump and the CMS Total interruption duration 0 01 total commu...

Страница 95: ...e 15 levels selectable 50 mmHg 150 mmHg 225 mmHg 300 mmHg 375 mmHg 450 mmHg 525 mmHg 600 mmHg 675 mmHg 750 mmHg 825 mmHg 900 mmHg 975 mmHg 1050 mmHg not applicable for 50ml 60ml syringe and 1125 mmHg not applicable for 50ml 60ml syringe The maximum occlusion pressure is 1350 mmHg For the 2 ml syringe or syringes larger than 2ml the selectable pressure ranges are as follows 0 01ml h rate 0 1 ml h t...

Страница 96: ...t range 0 1 to 499 0 kg 0 2 to1100 1 lb Drug Amt set range 0 001 to 99999 Drug Amt unit set range ng μg mg g mU U kU EU mmol mol mcal cal kcal mEq Volume 0 10 to 9999 99ml Conc set range 0 001 to 9999 99 Conc unit set range ng ml μg ml mg ml g ml mU ml U ml kU ml EU ml mmol ml mol ml mcal ml cal ml kcal ml mEq ml Dose Rate set range 0 001 to 99999 Product Name Size Manufacturer Sterile Hypodermic ...

Страница 97: ... vary depending on test conditions temperature and tube length Using syringe of a larger size and infusing at a lower rate may cause longer occlusion alarm delay Syringe size ml Rate ml h Occlusion alarm delay time hh mm ss High occlusion alarm pressure level Low occlusion alarm pressure level 20 1 00 33 12 00 02 12 5 00 06 54 00 00 45 50 1 01 45 57 00 06 53 5 00 25 15 00 01 42 Syringe size ml Rat...

Страница 98: ...uracy Graphs A 10 1 Infusion Accuracy at 1 ml h Observation window min Percentage error of flow Trumpet Curve at 1ml h 2nd hour Overall percentage error Ep Min Ep Max Rate ml h Time min Start up graph first 2 hours at 1ml h ...

Страница 99: ...Test interval t 0 5 minute WARNING Infusion accuracy may be influenced by the pump s environment such as pressure temperature humidity and any infusion consumables used Observation window min Percentage error of flow Trumpet Curve at 5ml h 2nd hour Overall percentage error Ep Min Ep Max Rate ml h Time min Start up graph first 2 hours at 5ml h ...

Страница 100: ...A 10 This page intentionally left blank ...

Страница 101: ...ally Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the this device including cables specified by the manufacturer Otherwise degradation of the performance of this device could result The non ME EQUIPMENT e g ITE that is a part of an ME SYSTEM may be disrupted by the electromagneti...

Страница 102: ...ice personnel Guidance and Declaration Electromagnetic Emissions The device is intended for use in the electromagnetic environment specified below The customer or the user of the device should assure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance Conducted and radiated RF EMISSIONS CISPR 11 Group 1 The device uses RF energy only for its interna...

Страница 103: ...t listed in Table Guidance and Declaration Electromagnetic Immunity the system will remain safe and provide the following essential performance Operating mode Accuracy Function Protection against UNINTENDED BOLUS volumes occlusion ALARM CONDITIONS regarded Data stored ...

Страница 104: ...ty should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Voltage dips and Voltage interruptions IEC 61000 4 11 0 UT for 0 5 cycle 0 UT for 1 cycle and 70 UT for 25 30 cycles 0 UT for 250 300 cycle 0 UT for 0 5 cycle 0 UT for 1 cycle and 70 UT for 25 30 cycles 0 UT for 250 300 cycle Ma...

Страница 105: ...he maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveyb should be less than the compliance level in each frequency rangec Interference may occur in the vicinity of equipment marked with the following symb...

Страница 106: ...150 kHz to 80 MHz field strengths should be less than 3V m Recommended Separation Distances between Portable and Mobile RF Communications Equipment and This Equipment The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distanc...

Страница 107: ... The radio device used in this product is in compliance with the essential requirements and other relevant provisions of Directive 2014 53 EU WARNING Keep a distance of at least 20cm away from the equipment when Wi Fi function is in use ...

Страница 108: ...B 8 This page intentionally left blank ...

Страница 109: ...International Special Committee on Radio Interference CPU Central Processing Unit DC Direct Current DERS Dose Error Reduction Systems DPS Dynamic Pressure System EEC European Economic Community EMC Electromagnetic Compatibility EMI Electromagnetic Interference EtO Ethylene oxide ICU Intensive Care Unit ID Identification IEC International Electrotechnical Commission ...

Страница 110: ...on for Standardization IV Intravenous KVO Keep Vein Open LED Light Emitting Diode Max Maximum MDD Medical Device Directive Min Minimum MRI Magnetic Resonance Imaging N A Not Applied OR Operating Room SN Series Number USB Universal Serial Bus VTBI Volume To Be Infused Abbreviation In Full ...

Страница 111: ...D 1 D Declaration of Conformity ...

Страница 112: ...D 2 This page intentionally left blank ...

Страница 113: ......

Страница 114: ...P N 046 021887 00 1 0 ...

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