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Fresenius Kabi Ambix activ, Instructions For Use Manual

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8.2

Electromagnetic compatibility and interference 

guidance 

Warning

Use of the 

Ambix activ

 pump adjacent to or stacked with other 

equipment should be avoided because it could result in improper 
operation. If such use is necessary, this equipment and the other 
equipment should be observed to verify that they are operating 
normally.

Use of accessories, transducers and cables other than those 
specified or provided by the manufacturer of the 

Ambix 

activ

 

pump could result in increased electromagnetic emissions or 
decreased electromagnetic immunity of the pump and result in 
improper operation.

Portable RF communication equipment (including peripherals 
such as antenna cables, internal and external antennas) should 
be used no closer than 10 cm for cell phones and 30 cm  for other 
equipment, to any part of the 

Ambix activ

 pump, including   

cables   specified   by   the   manufacturer. Otherwise, degradation 
of the essential performance of 

Ambix activ

 pump could result. 

The user might be required to take mitigation measures, such as 
relocating or re-orienting the equipment.
If the 

Ambix 

activ

 

pump is placed near RF communication equipment 

such as cell phones, DECT phones or wireless access points, RFID 
reader and tags, ... it is essential to observe a minimum distance 
between the 

Ambix 

activ

 pump and the equipment specified above. If 

the 

Ambix 

activ 

pump causes harmful interference or if it is itself 

disrupted, the user is encouraged to try to correct the interference by 
one of the following actions:
- Reorient or relocate the 

Ambix 

activ

 pump, the patient, or the 

disruptive equipment.

- Change the routing of cables.
- Connect the 

Ambix 

activ

 pump mains plug to a protected, backed-up, 

or filtered supply, or directly to a UPS (uninterruptible power supply) 
circuit.

- Increase the separation between the 

Ambix 

activ

 pump and the 

disruptive equipment.

- Connect the 

Ambix 

activ

 pump into an outlet on a different circuit from 

that to which the patient or disruptive equipment is connected.

If the problem remains, the pump shall not be used in such environment.
For further information on EMC compliance, please refer to the 

Ambix 

activ

 Technical Manual.

Summary of Contents for Ambix activ

Page 1: ...INSTRUCTIONS FOR USE Applicable to software version 2 3 ...

Page 2: ...ame and address of the manufacturing facility Direct Current DC Fragile handle with care Protection against electric shock class II This way up IP34 IP33 Splash protected Keep away from rain Part included in a recycling process Temperature limitation Degree of protection against electric shock type CF applied part Humidity limitation Nurse call Atmospheric pressure limitation Battery General symbo...

Page 3: ...3 Local Contacts for Servicing Write your contact here ...

Page 4: ...V PUMP SETS 15 2 4 BACKPACK FOR ADULTS AND FOR CHILDREN 16 3 OPERATING INSTRUCTIONS 17 3 1 PACKAGING 17 3 2 POWER SUPPLY 17 3 3 LOADING THE SET PATIENT NOT CONNECTED 18 3 4 OPERATING THE AMBIX ACTIV 19 3 5 PROGRAMMING THE AMBIX ACTIV 24 3 6 ADVANCED FUNCTIONS 28 4 DATA COMMUNICATION 34 4 1 INTERNAL DATA MANAGEMENT 34 4 2 History file 34 5 ALARMS SAFETY FEATURES 35 5 1 ALARMS 35 5 2 TROUBLESHOOTING...

Page 5: ...RFORMANCE 49 8 2 ELECTROMAGNETIC COMPATIBILITY AND INTERFERENCE GUIDANCE 50 9 WARRANTY INSPECTION AND REPAIR 51 9 1 WARRANTY 51 9 2 MAINTENANCE REQUIREMENTS 51 10 CLEANING AND DISINFECTING 53 10 1 CLEANING INSTRUCTIONS 53 10 2 DISINFECTION INSTRUCTIONS 54 11 ORDER INFORMATION 55 ...

Page 6: ...mbix activ pump is a mobile portable stationary reusable device the pump ensures fluid delivery in Continuous Volume over time Intermittent mode Ramp mode It uses a pumping and clamping fingers mechanism for advancing the liquid to the patient through a dedicated set Ambix activ is intended for children and adults that require parenteral nutrition It is not suitable for neonatal 1 month use Operat...

Page 7: ... hPa Altitude maximum 3000 m The pumps administers products through intravenous IV access Not for use with life sustaining critical application drugs or drugs with short half life Not designed for infusion of insulin Not for use at flow rates below 10 ml h Not suitable for neonates Warning Keep the pump sets holder and cables away from unsupervised children and animals Consider the following opera...

Page 8: ...ose as possible to the patient with cable and set arranged so to minimize the risk of accidental disconnection by the operator or a person in vicinity of patient The operator should be located in a position to be able to see the pump display and have access to pump keypad for alarm condition clearance In order to ensure that all safety features are activated switch pump ON before being connected w...

Page 9: ...tromagnetic radiation The pump should only be connected to the wall outlet with the power cord supplied by the manufacturer Check that the line power voltage corresponds with the value indicated on the device label Do not exceed the permitted voltage on the external connections A non medical electric device connected to the device must conform to the suitable IEC EN standard e g IEC EN 60950 and I...

Page 10: ...ate at the beginning and a decreasing flow rate at the end Programmable ramping up and down times are entered by the user Information Calculation rule When a Volume over time mode is programmed the rate is calculated according to the following rule R V T R Rate V Volume to Be Infused T AdministrationTime Features Rate range 10 to 600 ml h Increments of 1ml h from 10 to 100 ml h Increments of 5 ml ...

Page 11: ...e rolling stand Serial number label Unit number Pump door Door lever Contacting prongs for connecting to pump holder Guide rail IV set Pump Pump holder Insert point for the pole stand to suspend the administration system Clamping device Screw to lock the clamping device The clamping device can be rotated 180 The pump can be attached universally vertically and horizontally to both round and square ...

Page 12: ...call connection Depress button to release pump Keypad lock Information and OK reset given volume dose time last dose Start pumping Stop pumping or escape Activate target volume Set target volume Set time thresholds Set flow rate Change mode Enter parameter menu Alarm silence Pump priming Reset pump to factory settings Switch pump on off ...

Page 13: ...active Volume Time mode Volume Time mode is active Ramp mode Ramp mode is active Intermittent mode Intermittent mode is active Active ramping phase Active phase of the ramping procedure will flash Priming mode Pump is priming Battery charging status Charging status of the internal battery pack empty battery nearly empty battery partially charged battery fully charged battery Information mode Mode ...

Page 14: ...ted to this port determines the function used Data interface Only used for maintenance The pump must not be connected to a patient This feature is available when the pump is properly engaged in the holder and the holder is connected to the AC wall outlet Further information about connectivity is available from the technical service department Cable references are accessible on the Technical Manual...

Page 15: ...V Anti syphoning valve the pressure level may be changed see warning Section 1 9 page 8 When set is out of the pump ensure that the clamp is closed especially when the container is placed above the injection site or that the set is disconnected from the patient The Ambix activ is designed to operate exclusively with the appropriate Fresenius Kabi activ sets including the patented activ clamp see o...

Page 16: ...gh the front window The activ Rucksack can be carried using the top handle the shoulder straps or worn on the back The activ Rucksack mini is suitable for carrying up to 1 5 litres with the pump The activ Rucksack mini can be carried using the top handle or the shoulder straps It also has a hanging strap from hang from a baby carriage When the activ Rucksack is used the pump display and keypad are...

Page 17: ... connected to the wall outlet When the pump is disconnected from the outlet it automatically switches to battery mode The maximum battery life is achieved after several charge discharge cycles When the pump is used in stationary connect the pump holder to the mains supply The battery should be fully charged before every ambulatory use and check the battery is fully charged The power outlet on acti...

Page 18: ...p 3 Place the upper ring of the blue kink protector in the blue coloured notch Take care that the pumping segment of the tubing is in front of the pump mechanism 4 Close the pump door and push the lever down The activ clamp will open automatically Flow will be prevented by the pumping mechanism until administration is started 5 If applicable open roller clamp after set installation before starting...

Page 19: ...red to restart the pump repeat the installation procedure described above in Section 3 3 1 page 18 Press the On Off button for more than one second to switch the pump on The pump will boot and will perform a self test The most recent parameters and program will be shown in the display Press the On Off button for more than three seconds to switch the pump off The display will count down 3 2 1 off a...

Page 20: ...e pump primes the line at 600 ml h During priming the empty bag alarm is deactivated and a short beep sounds every 2 seconds Warning Never prime the set with a patient connected Information Check the integrity of the set prior to connecting the patient The empty bag alarm is disabled while the pump is priming Warning When priming stationary sets do not forget to open the roller clamp After priming...

Page 21: ... pump has to be switched off After switching the pump on again a new program can be set and started By pressing the i OK button the total volume infused since the last reset will be displayed for 5 seconds will be shown in the display If the pump is running and the target volume is activated the remaining volume will then be displayed will be shown in the display When the pump is not pumping press...

Page 22: ...ivated only the following buttons are active On Off button Switches pump on and off Start button Continues the infusion after an alarm without unlocking the keypad Stop Esc button Stops administration when pump is running an alarm will appear Stop Esc button Clears the alarm permanently Alarm silence button Silences alarms for two minutes Info button Accesses info function To exit the info functio...

Page 23: ...ble lock mode press the Lock button and the Alarm silence button simultaneously to leave the parameter menu To disable Lock mode enter the parameter menu by pressing the Lock button and the Alarm silence button simultaneously and press the Mode button once and the mode symbol will flash again Press the Lock button and the Alarm silence button simultaneously to leave the parameter menu Information ...

Page 24: ...witch pump off Button Action ON OFF Switch pump on MODE Change to volume time mode Middle row Set application time Lower row Set target volume START Start pumping Information The flow rate will be calculated and displayed automatically If the configured limit of the flow rate is reached other parameters are also limited To abort the program switch pump off Button Action ON OFF Switch pump on MODE ...

Page 25: ...s and hold the stop and i OK buttons when the pump is stopped The time and the volume will be counted regardless of whether the pump was turned off If the infusion duration exceeds 24h the display shows If the infusion is stopped during the dose the infusion will resume by pressing the START button All other doses will be delayed for the same amount of time To abort the program switch off or reset...

Page 26: ...rmation To abort the program switch pump off The current rate the remaining time and the remaining volume to be administered will be calculated automatically and displayed Press the STOP button once during the ramp program to stop the infusion Stop will be shown for 3 seconds in the lower line of the display Press Start to resume the program For immediate ramp down the Mode and Start button have t...

Page 27: ...container than the programmed target volume The standard display of time over 10h is in full hours except if the option steps of 5 minutes is activated Note For an infusion time greater than 10 hours minutes can be programmed in increment of 5 minutes by pressing simultaneously the and keys The minutes appear on the display for 5 seconds 00h then use and keys to adjust To confirm minutes press the...

Page 28: ...ow rate 25 Change password The alteration of parameters always follows the same logic First select the parameter that is to be altered using the upper row of buttons Then alter the value of that parameter using the lower row of buttons The change should be confirmed with the i OK button or cancelled with the STOP ESC button Information The alterable value flashes Button Action Upper Select numeric...

Page 29: ...t between 0 and 250 preset is 3 i OK Confirm the password The Ambix activ can perform a Keep Vein Open KVO function This function will continue the infusion at a low rate after the target volume is reached in order to keep the vascular access device and vein open The KVO function is available in all modes except continuous mode with deactivated target volume The setting of the KVO is between 0 dea...

Page 30: ...level is from 0 7 bar to 1 8 bar Information During pumping a display graphic will indicate the pressure See page 12 Button Action Upper Select 3 from the menu to enable pressure sensitivity change Lower Change to the desired value HI LO preset HI i OK Confirm the adjusted value Alarm sound level settings are HI High ME Medium and LO Low When an alarm is triggered the configured value will be indi...

Page 31: ...t come on for 10 seconds In case of alarm the backlight will flash If the pump is connected to a wall outlet there are 3 possible settings Off Same as in battery mode On The backlight is always on Alarms will be indicated by flashing of the backlight Temp Same as in the ON setting but when unplugged stays on for 10 seconds only Button Action Upper Select 5 from the menu to enable backlight status ...

Page 32: ...is not reached The alarm is deactivated when the value is 0 Ensure that the setting is appropriate for the patient Button Action Upper Select 8 from the menu to enable change to percentage of volume for end alarm Lower Change to desired value 0 100 Preset is 10 i OK Confirm the adjusted value The time between alarms can be adjusted to between 5 and 300 seconds in increments of 5 seconds Button Act...

Page 33: ... change to maximum flow rate Lower Change to desired value between 100 and 600 ml h Preset is 600 ml h i OK Confirm the adjusted value The password for entering the parameter menu can be set between 0 and 250 to prevent access by unauthorized persons This menu is only visible if the password is entered correctly in menu 1 Button Action Upper Select 25 from the menu to change the password for the p...

Page 34: ...g the last switch off provided the battery was fully charged at switch off For more details see the technical manual Every event will be stored in the history file The history file has a maximum capacity of approximately 500 events The events are stored using a FIFO first in first out procedure for 5 years This means that after the maximum capacity is reached the first stored event will be deleted...

Page 35: ...m Check position of activ Set above and below the pump mechanism and insert correctly if necessary Use recommended activ sets Clean the clamp and wipe using a lint free cloth lightly dampened with warm water and a mild detergent or disinfectant or follow the recommended local procedure Allow the pump to dry For cleaning procedures see page 53 High Pump mechanism blocked yes alarm Tubing set may be...

Page 36: ...nfectant or follow the recommended procedure Allow the pump to dry For cleaning procedures see Cleaning and Disinfecting page 53 Check the position of the set and insert correctly High Batteries are defective not charging correctly Pump is plugged in at the wall outlet no alarm Contact service Low Battery pre alarm no warning Battery will be depleted in 30 minutes Plug pump into the wall outlet Hi...

Page 37: ...m Check programming parameters and press Start to infuse Low Pump is infusing at KVO keep vein opened no alarm The volume to be infused is completed Press Stop to select a new infusion setting if required Wrench Preventive maintenance no Informa tion signal Perform for maintenance High Technical error yes alarm Contact your Fresenius Kabi sales representative or the local distributor Blinking Symb...

Page 38: ... department or Fresenius Kabi After Sales Service if problem remains Front panel problem keys backlight Check the general state of the front panel Plug the pump to mains and check lightning of backlight Contact your biomedical department or Fresenius Kabi After Sales Service if problem remains The Power Indicator LED does not light up Connect the holder to the mains supply Contact your biomedical ...

Page 39: ...taining solutions could impair the air removal function of the filter The Ambix activ administers a maximum of 10 ml under single fault conditions The Activ set is a Type CF applied part It can be in contact with the patient without time limitation during the operating life of the Activ set Warning The outer enclosure of AMBIX Activ pump and HOLDER are also considered to be applied parts When oper...

Page 40: ... check that they are replicated on the nurse call system Power indication Connect the holder with attached pump to the wall outlet Verify that the two prongs plug symbol appears in the display and the green LED on the holder lights up Battery Charge After complete charging check the battery level indicator Incorrectly installed set Start infusion without installed set Check that the alarm is set o...

Page 41: ...open door alarm is activated Air alarm active Check that the symbol is not displayed Reset pump if the symbol is displayed Warning In case of test failure or any doubt regarding the integrity of the pump please do not use the device If one or more checks do not comply with the right pump behaviour please contact the appropriate department or Fresenius Kabi After Sales Service for additional verifi...

Page 42: ... V 10 50 60 Hz 14 VA Pump holder output 7 75 V 800 mA Battery type NiMH 4 8 V 1 8 Ah Nickel Metal Hydride Battery life 40 hours at 125 ml h The maximum battery life could only be achieved after several charge discharge cycles Avoid short circuit and excessive temperature Equipment group Class IIb Medical Devices Directive 93 42 EEC Class III Canadian Medical Devices Regulations SOR 98 282 Environm...

Page 43: ... is removed Battery replacement must be performed by qualified and trained technical personnel in compliance with the technical manual and procedures Table 7 2 1 Maximum time for activation of occlusion alarm at different flow rates and Bolus volume generated when pump operating at 125 ml h and reaching the minimum and maximum occlusion alarm threshold Occlusion alarm treshold LO Low HI High Flow ...

Page 44: ... to obtain these results is described in IEC60601 2 24 The curves can be helpful in determining the suitability of infusion parameters for specific drugs and concentrations Set used activ Set ambulatory Fluid used ISO class III water 7 3 1 Minimum flow rate 10 ml h Data as evaluated by the test methods of IEC 60601 2 24 Sampling time 30 seconds Figure 7 1 Start up and instantenous flow rate 10ml h...

Page 45: ...umpet curves For 2 5 11 19 31 minutes observation windows 10 ml h over last hour of the set change interval 24h Sampling time 15 minutes Figure 7 5 Instantenous flow rate 10ml h over set change interval 24h Sampling time 15 mins Figure 7 6 Trumpet curves For 15 60 150 330 570 930 minutes observation windows 10 ml h over set change interval 24h ...

Page 46: ...intermediate flow rate 125ml h over first 2h of the test period Sampling time 30 seconds Figure 7 8 Trumpet curves For 2 5 11 19 31 minutes observation windows 125 ml h over second hour of the test period Sampling time 30 seconds Figure 7 9 Instantenous rate 125 ml h over last 2h of set change interval 24h ...

Page 47: ...ws 125 ml h over last hour of the set change interval 24h Sampling time 15 minutes Figure 7 11 Instantenous flow rate 125ml h over set change interval 24h Sampling time 15 minutes Figure 7 12 Trumpet curves For 15 60 150 330 570 930 minutes observation windows 125 ml h over set change interval 24h ...

Page 48: ...h the container cannot be placed below 15 cm Warning Accuracy flow rate volume infused pressure can be influenced by fluid viscosity fluid temperature and TPN product that is not fully compatible with a 1 2 micron filter on the set Note All tests below are in accordance with the IEC 60601 2 24 standard and tested with ISO Class III water Accuracy Cumulative Flow Rate 5 for 24 hours Accuracy Effect...

Page 49: ...es Proximity with electrosurgical unit cables and electrodes The customer or user of the Ambix activ pump must ensure that it is not used in such environments Excluding the cases described in this manual the pump operation must systematically be checked by a qualified operator should the pump be installed in the vicinity of other electrical devices In standard operating conditions homecare nursing...

Page 50: ...e user might be required to take mitigation measures such as relocating or re orienting the equipment If the Ambix activ pump is placed near RF communication equipment such as cell phones DECT phones or wireless access points RFID reader and tags it is essential to observe a minimum distance between the Ambix activ pump and the equipment specified above If the Ambix activ pump causes harmful inter...

Page 51: ...of the IEC regulations the pump is used as specified in these Instructions for use according to its intended use as defined in Section 1 1 page 6 the pump is operated with the sets specified by the manufacturer see Section 2 3 page 15 The recommended maintenance interval for the Ambix activ and the pump holder is two years or the application of 1 000 litres equivalent to 8 000 hours at 125 ml h Th...

Page 52: ...disposal remove battery from the device Battery and devices with this label must not be disposed of with the general waste They must be collected separately and disposed of according to local regulations For further information pertaining to waste processing regulation contact your local Fresenius Kabi organisation or the local distributor ...

Page 53: ...oroughly wipe down all exposed surfaces housing keyboard holder connection area etc of the pump from top to bottom Gently wipe down the exposed mechanism of the pump and the sensor area tube guide clamp insert A cleaning process of 1 minute minimum is recommended allow to remain visibly wet for 1 minute until all organic matter is dissolved and removed Do not allow liquids to run leak or drip into...

Page 54: ...g disinfection do not turn the pump upside down to avoid liquid leaking into the pump 3 Use a ready to use wipe to wipe down all exposed surfaces of the pump holder and pump door as described in cleaning protocol making sure to cover all cracks crevices and hard to reach areas Do not allow liquids to run leak or drip into the pump housing 4 Using a fresh ready to use wipe repeat steps 3 Ensure tha...

Page 55: ...2892098 activ Set stationary SF 15 2892091 activ Rucksack 1 2892101 activ Rucksack mini 1 Accessories Rolling stand 1 For any assistance if needed in setting up using or reporting unexpected operation or events please contact your homecare provider Fresenius Kabi can be contacted at the following address Fresenius Kabi AG 61346 Bad Homburg Germany Fresenius Vial S A S Le Grand Chemin 38590 Brézins...

Page 56: ...3325 10_ifu_Ambix_Activ_INT ...

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