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Micrel Rhythmic evolution Instructions For Use Manual

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Paul Oakley
March 19, 2025

How do I enter four hours for infusion numerically? I tried to do so but think I accidentally have set it for forty hours, please help asap

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Summary of Contents for Micrel Rhythmic evolution

  • Page 1 Instructions For Use...
  • Page 2 Keep for future reference Technical Assistance If you have comments or questions concerning the operation of your Rythmic™pump or you need technical assistance, please contact your local Micrel’s Authorized Distributor or contact Micrel Customer Support at info@micrelmed.com or call at +30 210 6032333-4.
  • Page 3 Warnings • The supervisor of the infusion must decide whether the Configuration chapter should be kept in the present IFU. • We recommend the default codes of the pump to be changed ( through the configuration menu) in order to secure the access to different actions related to each code. •...
  • Page 4 Warnings • Ensure that air has been purged from the administration set before connecting it to a patient to prevent air embolism. • Ensure that air has been removed from Y connector. Air embolism could result in death or serious injury to the patient. •...
  • Page 5 • Do not use other external power adaptor than the ones supplied by Micrel. • Do not plug the Micrel power adaptor to the Mains with wet / moist hands. • The pump should be disconnected from the patient prior to being connected to a computer.
  • Page 6 Warnings • Ensure that accessories are not attached to the pump, are not ON or connected to the Mains before commencing the cleaning / disinfection procedure. • Always validate infusion protocol values by checking all parameters, prior to start the infusion.
  • Page 7 • Do not remove the internal battery (9V alkaline or rechargeable) from the pump while it is connected to Micrel power adaptor or IP Connect Pack accessory. • Prior to using pump with rechargeable battery for the first time, use the power adap- tor to fully charge the internal rechargeable battery.

  • Page 8: Table Of Contents

    Contents 1. General Description 1.1 Introduction 1.2 Pump Layout 2. Preparation of infusion 2.1 Opening the transparent covers 2.2 Locking the transparent covers 2.3 Power Supply 2.3.1 For pumps with 9V alkaline battery 2.3.2 For pumps with rechargeable battery 2.4 Pre-Use checklist 2.5 Preparation of administration sets before the infusion 2.6 Fitting the Administration set into the pump 3.
  • Page 9 6. Operation of pump 6.1 Priming the Administration set line 6.2 Placement of the pump 6.3 Changing the bag for the same patient (New bag) 6.4 Resuming the same infusion with the same patient after power off of the pump (Resume after power off) 6.5 Changing the battery and continue the same infusion 6.6 Changing the Protocol 6.7 Clinician Bolus override...
  • Page 10 10.5 Using carrying bag and carrying belt. 10.6 Using IV pole clamp. 10.7 Accessories 11. Precautions & Maintenance 11.1 Routine Maintenance Procedures 11.2 Cleaning and disinfection 11.2.1 Cleaning procedure for pump 11.2.2 Disinfection procedure for pump 11.2.3 Cleaning and disinfection procedure for accessories 11.3 Storage 11.4 Disposal 12.

  • Page 11: General Description

    1. General Description Pump 1.1 Introduction The Rythmic™ pump is a technologically advanced, easy to use infusion pump, designed to provide best comfort, precision, safety and durability for many years to come. The Rythmic™ pump offers many quality features that make it highly suitable for today’s hospital and home care treatments.
  • Page 12 When unpacking, check that the system is complete and undamaged. Systems include the below: Rythmic™ Rythmic™ Evolution Evolution Rythmic™ Rythmic™ Mini Mini Rechargeable & Evolution Evolution Rythmic™ I T E M & Rythmic™ Evolution Evolution Organiser Organiser Evolution Evolution Organiser Rechargeable Organiser Protective...

  • Page 13: Pump Layout

    1.2 Pump Layout Mini                     Transparent cover   Tubing cover  Tubing cover release lever   Opening system  Injection / filling port ...
  • Page 14 C O N T R O L S A N D D I S P L A Y On/Off key Soft keys Start / Stop key function depends on the respective display symbol Enter key Purge/Bolus key or label Turn the pump ON or OFF by pressing and holding the key for 2 sec. Start and stops priming the line and during infusion generates patient bolus demands, if bolus handset is not connected.

  • Page 15: Preparation Of Infusion

    2. Preparation of infusion 2.1 Opening the transparent covers To open the transparent covers please follow the steps below: Step 1: Verify that the pump is switched OFF. Step 2: Remove the pump from the carrying bag or the pole clamp and then follow the procedure as shown for each model accordingly.

  • Page 16: Locking The Transparent Covers

    Mini Insert the key or the permanent key and turn gently clockwise in the orientation shown to open the transparent cover. The user can configure the cover so it can be used without being locked. To insert the permanent key on transparent cover please follow the below steps. ...

  • Page 17: Power Supply

    2.3 Power Supply 2.3.1 For pumps with 9V alkaline battery Applies to models: Rythmic™Evolution, Mini Rythmic™ Evolution, Rythmic™ Evolution Organiser 500/100. Warning • Do not use rechargeable NiCd or NiMH batteries. Do not use carbon zinc batteries. • Ensure that the battery placed in the pump is in good condition and the remaining battery power is enough for the infusion that is going to start.

  • Page 18: For Pumps With Rechargeable Battery

    Caution • Check that the polarity of the 9V alkaline battery is correctly oriented. • Check that the battery door has been closed; otherwise the transparent covers may not close. • Do not remove the 9V alkaline battery while the pump is switched ON, as this may damage the pump.

  • Page 19: Pre-Use Checklist

    Charging the rechargeable battery Warning Do not use other external power adaptor than the one supplied by Micrel. In extreme cases of electromagnetic interference, Alarm C-05 may arise. There is no special problem with the pump, just follow the alarm handling instructions of this IFU.
  • Page 20 Before use the pump and it’s accessories to carry out an infusion, run the following test for a complete alarm and safety features check for both pump and accessories. Pump’s Serial number (S/N): ..........Date: ../ ../ ..Accessory information (description) : …………………........…….

  • Page 21: Preparation Of Administration Sets Before The Infusion

    • Do not administer medications to the epidural space unless these medications are indicated for epidural space infusion. Micrel offers a large variety of sets, the Full set range and the Spike set range, tailored for different medical applications. Rythmic™ administration sets are considered as applied part of the pump and are made of biocompatible materials according to ISO 10993 series of standards.
  • Page 22 All administration sets are single use products, sterile using ethylenoxide and are equipped with: An in line air eliminating filter to ensure that any air trapped within the fluid is not delivered to the patient. Anti-siphon valve to prevent free flow, if the set is removed unclamped from the pump while still connected to the patient.
  • Page 23 For administration sets with bag, Prepare the medication for treatment. Prepare the infusion sets according to the instructions below and hospital protocols. 1. Unwrap the set. 2. Clamp the tube to inhibit flow. 3. Ensure that the syringe is fully screwed into the valve. 4.
  • Page 24 properly eliminated any air while priming the administration set. If the filter is not properly eliminating the air and air bubbles are observed in the line, then the administration set must be changed. 10. Continue to squeeze the bag gently until the liquid passes through the line and exits from the anti-siphon valve, in order to fully prime the line manually.
  • Page 25 Warning • Ensure that air has been purged from administration set before connecting it to a patient, to prevent air embolism. • Extra care must be taken when using administration sets with Y connector. Ensure that air has been removed from Y connector. Air embolism could result in death or serious injury to the patient.

  • Page 26: Fitting The Administration Set Into The Pump

    2.6 Fitting the Administration set into the pump Sets with reservoir, Rythmic™ Full Sets Rythmic™ Full Sets can only fit in Rythmic™ and Mini Rythmic™ Evolution models. Warning • Ensure that the slide clamp is closed before removing the administration set from the pump, to prevent free flow of medication.
  • Page 27 5. Load the tubing into pumping mechanism. It can only be loaded one way round. Check that the pressure sensor is located under the door and positioned with the membrane facing downwards. The locating key should be correctly orientated. The tube shall exit the pump and connect to the patient side.
  • Page 28 For sets with Spike and external medication container, Rythmic™ Spike Sets Rythmic™ Spike Sets can fit in all models of Rythmic™ Evolution range. Warning • Ensure that the slide clamp is closed before removing the administration set from the pump, to prevent free flow of medication. •...
  • Page 29 5. Close the tubing cover firmly. For Rythmic™ Organiser: Close the door hood firmly. Warning • Ensure that the administration set has been properly installed and has not been trapped in transparent covers, as this may result in under or non-delivery of medication. •...

  • Page 30: Pump Functions And Terms

    3. Pump Functions and Terms 3.1 Delivery modes The Rythmic™ Evolution pump offers 4 delivery modes. Continuous, this delivery mode gives the ability to infuse at a constant basal rate only. The infusion can be set in ml/hr or in mg or μg (mcg) entering a concentration (per ml). The basal rate and volume to be infused should be programmed.
  • Page 31 Auto Bolus (standing for Programmed Automatic Bolus – PAB), this delivery mode gives the ability to infuse automatically boluses with specified frequency in parallel to optional basal rate and patient bolus. This mode enables Basal rate, Automatic Bolus dose, Automatic Bolus Frequency, patient Bolus dose, Lockout interval, Dose limit or Bolus limit, Loading dose and Volume to be infused.
  • Page 32 Time When the loading dose is used, the timer of the automatic bolus frequency and the timer of the lock out interval of the bolus are starting at the end of the delivery of the loading dose. If the loading dose is not used, the first automatic bolus will be delivered after the elapsed time of the automatic bolus frequency, which has begun after the start of the infusion.

  • Page 33: Definitions Of Terms Used

    3.2 Definitions of terms used Basal rate  The basal rate is a continuous flow rate that can be programmed in ml/h, mg/h or μg/h. The infusion ends when the programmed Volume To Be Infused has been delivered. Concentration  The drug concentration is required to calculate the basal rate while programming units mg or μg are used, with the following formula.
  • Page 34 Automatic Bolus Frequency  The automatic bolus frequency (also called Auto Bolus Frequency on the pump screen) defines the period of time between two automatic boluses. Dose limit  The dose limit gives the capability to restrict the amount of drug that a patient can get within a period of time.
  • Page 35 Volume to be infused  The volume to be infused parameter is used to trigger the near end of infusion alarm and then later to trigger the end of infusion alarm. Usually the volume to be infused value is the bag volume minus the primed volume. The volume to be infused value, displayed on the pump screen, will decrease during the course of the infusion whilst the infused volume will increase accordingly.

  • Page 36: Actions And Codes

    4. Actions and codes Warning • We recommend the default codes of the pump to be changed (through the configuration menu) in order to secure the access to different actions related to each code. • The supervisor of the infusion should decide to whom each code and its related actions should be distributed.

  • Page 37: Programming Procedure

    5. Programming procedure Warning • We recommend the default codes of the pump to be changed (through the configuration menu) in order to secure the access to different actions related to each code. • The supervisor of the infusion should decide to whom each code and its related actions should be distributed.

  • Page 38: Selecting The Delivery Mode

    5.2.1 Selecting the delivery mode After turning ON the pump, the delivery mode is displayed graphically on the upper right corner on screen. Note: The default delivery mode is the “Continuous + Bolus” CODE: mode. After initial use, the mode displayed on the screen will 0000 be the one set at the previous infusion.

  • Page 39: Select Programming Units

    5.2.3 Select programming units At the beginning of programming procedure, it is possible to select the programming unit from ml, mg and μg. When mg and μg programming units are used, entering the drug concentration is required. Press the soft key to select the programming unit from either the rate screen UNITS or the concentration screen.
  • Page 40 Select one of the two limits by pressing the appropriate SELECT LIMIT key. DOSE BOLUS PER  LIMIT HOURS Enter the DOSE LIMIT value in minutes and press 2 MAX BOLUS DOSE DOSE LIMIT observation window can be changed in this LIMIT 0180 m1/4hr...

  • Page 41: Programming Procedure Continuous Mode

    Warning • Ensure that air has been purged from the administration set before connecting it to patient, to prevent air embolism. Air embolism could result in death or serious injury to the patient. • Do not prime the administration set while it is connected to a patient, as this may result in air embolism or over- delivery of medication.
  • Page 42 Warning Always validate infusion protocol values by checking all parameters, prior to start the infusion. If the Protocol values are not correct, please, restart the programming procedure by pressing when you are on the "PUMP ON HOLD" screen. At the end of programming a summary of the protocol VOL TB INF 160.0 appears on the screen, the programmed value of each...

  • Page 43: Programming Procedure Bolus Only Mode

    5.2.6 Programming procedure Bolus only mode Enter the patient BOLUS dose value and press BOLUS Enter the LOCKOUT INTERVAL value in minutes and press LOCKOUT INTERNAL If this parameter is not required, the value 000 should be entered. Select one of the two limits by pressing the appropriate SELECT LIMIT DOSE BOLUS...
  • Page 44 If Protocol is correct, press twice to start the infusion. 11 APR 2014 11:45 PUMP ON HOLD HISTORY PROTOCOL PROGRAM Warning • Ensure that air has been purged from the administration set before connecting it to patient, to prevent air embolism. Air embolism could result in death or serious injury to the patient.

  • Page 45: Programming Procedure Automatic Bolus Mode

    5.2.7 Programming procedure Automatic Bolus mode Enter the BASAL RATE value and press BASAL RATE: You can change the programming units in this screen by using the 000. ml/hr soft key, please refer to Chapter 5 paragraph 5.2.3 UNITS UNITS “Select programming units”.
  • Page 46 Enter the LOADING DOSE value if required and press LOADING DOSE Note: If this parameter is not required, the value 000.0 should be entered. Enter the VOLUME TO BE INFUSED value and press MAX/ 24H 1010m1 MAX/24H volume indication at the top of the screen indicate VOLUME TO BE INFUSED 0160 the maximum volume that a patient can receive within 24...

  • Page 47: Pre-Programming The Pump

    Warning • Periodically inspect the fluid path for air. If air is seen stop infusion. Air infusion could result in under or non-delivery of medication. Air embolism could result in death or serious injury to the patient. • Periodically inspect the fluid container for decreasing volume, inspect the fluid path for kinks, a closed clamp or other upstream obstruction.
  • Page 48 Warning • Ensure that air has been purged from the administration set before connecting it to patient, to prevent air embolism. Air embolism could result in death or serious injury to the patient. • Do not prime the administration set while it is connected to a patient, as this may result in air embolism or over- delivery of medication.

  • Page 49: Programming Through Protocol Library

    5.3 Programming through protocol library If the pump has been configured with Protocol Libraries through the Rythmic™ Evolution Therapy Manager PC application, then the programming procedure below should be followed. Rythmic™ Evolution Therapy Manager is part of the Rythmic™ Manager Pack reference KP5.04.250.x.
  • Page 50 If Protocol is correct, press twice to start the infusion. 11 APR 2014 11:45 PUMP ON HOLD 1V MORPHINE HISTORY PROGRAM PROTOCOL Warning • Ensure that air has been purged from the administration set before connecting it to patient, to prevent air embolism. Air embolism could result in death or serious injury to the patient.

  • Page 51: Operation Of Pump

    6. Operation of pump 6.1 Priming the Administration set line Warning • Ensure that air has been purged from the administration set before connecting it to patient, to prevent air embolism. Air embolism could result in death or serious injury to the patient.
  • Page 52 Priming of the administration set through the pump, using the below procedure. The same process is followed for both sets with bag and sets with spike and external medication container. Ensure that the set is unclamped. Press for a few seconds until priming begins. Press 11 APR 2014 11:45 again to stop priming.

  • Page 53: Placement Of The Pump

    6.2 Placement of the pump Warning • Ensure that the spike connector is properly attached to the external medication container. Spike detachment from the external medication container could result in under or non-delivery of medication. • When rigid - non collapsible external medication containers (e.g. glass bottles, hard plastic bag) are used with a Rythmic™...

  • Page 54: Changing The Bag For The Same Patient (New Bag)

    6.3 Changing the bag for the same patient (New bag) This function allows repeating the same protocol and changing only the volume to be infused parameter. The rest of the protocol parameters will remain the same. It also allows reviewing infusion protocol, infused volume, patient bolus demanded / patient bolus delivered.
  • Page 55 Protocol’s parameters are shown in summary. VOL TB INF 160.0 BOLUS Press to scroll down the protocol. LOCKOUT LOAD DOSE BOLUS / H 10BOL Warning Always validate infusion protocol values by checking all parameters, prior to start the infusion. If the Volume to be infused value is not correct, please, modify it by pressing to get on the relevant screen.

  • Page 56: Resuming The Same Infusion With The Same Patient After Power Off Of The Pump (Resume After Power Off)

    During infusion, user can access “Change bag” following the below procedure: Put the pump on hold by pressing twice and then 11 APR 2014 11:45 STOP press PROGRAM PUMP ON HOLD HISTORY PROGRAM PROTOCOL Enter new bag code and press CODE: 0000 Repeat the procedure described above in order to enter the new Volume to be Infused and to...

  • Page 57: Changing The Battery And Continue The Same Infusion

    Warning • Periodically inspect the fluid path for air. If air is seen, stop infusion. Air infusion could result in under or non-delivery of medication. Air embolism could result in death or serious injury to the patient. • Always validate infusion protocol values by checking all parameters, prior to start the infusion.

  • Page 58: Clinician Bolus Override

    Scroll down the screens by pressing until you reach the para-meter you need to change. Modify this parameter and press Scroll down to the “PUMP ON HOLD” screen and Press 11 APR 2014 11:45 Titr twice to resume the infusion. PUMP ON HOLD HISTORY PROGRAM...

  • Page 59: Bolus Administration

    6.8 Bolus administration Bolus administration can be achieved by using bolus handset or by using Purge-Bolus button placed on pump’s panel. The patient bolus is delivered if the pump is not in alarm condition and if the lockout interval since the last bolus has elapsed. The bolus handset supplied is designed to be used in either hand and suitable for both adult and pediatric use.

  • Page 60: Answering To Pain Level Question

    6.9 Answering to Pain level question Pain level question can be manually accessible as described below: Press when the pump is on hold or during infusion. 11 APR 2014 11:45 PUMP RUNNING HISTORY PROTOCOL Press to enter the questionnaire. DO YOU WANT TO ANSWER QUESTIONS ? Press the –...

  • Page 61: Historical Data & Event Log

    7. Historical Data & event log 7.1 Overview The pump keeps track of the following groups of information: 1. Infusion protocol Current active protocol (even after modification / titration from the user). 2. Infusion progress and patient bolus counters total and per hour Volume infused to patient &...

  • Page 62: Viewing Infusion Progress And Bolus Counters Per Hour

    This screen displays the Infused Volume and the volume SINCE: 11 APR 2014 11: 22 INFUSED BOLUS infused due to patient bolus. 97.0 ml 10.0 ml Bolus demand This indicates the number of patient bolus demand, arising from either the patient handset or the bolus button.

  • Page 63: Viewing Infusion Graphs During Running/Pump On Hold

    7.4 Viewing infusion graphs during running / pump on hold Infusion graphs are accessible either during infusion or when the pump is on hold. Press key at any time to review patient bolus demand, patient bolus given HISTORY and infused volume. Press the key to review the current infusion HISTORY...

  • Page 64: Infusion Events Log Overview

    7.5 Infusion events log overview Infusion events are only accessible through uploading event log to PC. These include: User Interface warnings, User Interface Alarms, Pump On/Off events, Infusion Start/ Stop, Priming Start/Stop, Loading Dose, Bolus Start/Given/Demanded, Titration, New Bag and Resume after power off. 7.6 Viewing infusion data even after turning off the pump If the pump has been turned OFF, it is possible to review the above mentioned infusion...
  • Page 65 In order to perform event log upload of the infusion data please follow the instructions shown below: 1. Connect the MicrelCom cord to the pump into the socket labelled on the pump. 2. Connect the other side of the MicrelCom cord to the PC. 3.

  • Page 66: Uploading Detailed Event Log

    Data will be displayed on the computer screen as shown below: MicrelCom cords are available at Micrel. 7.7.1 Uploading detailed event log After uploading the infusion data, there is the possibility to upload the detailed event log. Press to upload them or not and return to the selection screen.

  • Page 67: User Interface Alarm And User Interface Warnings

    8. User Interface Alarms and Warnings The Rythmic™ Evolution pump has means to make the user aware of any eventual equipment malfunction, and/or wrong operator equipment usage, and/or abnormal physiological conditions. There are three categories: User Interface Warnings, User Interface Alarms and Technical Alarms. 8.1 User Interface Warnings Whenever user interface warnings are produced, the infusion continues and an identification message is displayed.
  • Page 68 No patient bolus allowed Warning message Type of signal Cause Action A patient bolus is Wait for the time limit Audible NO BOLUS NOT demanded but not to pass. Patient bolus Visual AUTHORISED BEFORE 0'20'' allowed eg: during will automatically be bolus infusion, authorized after the limit during lockout time...

  • Page 69: User Interface Alarms

    Keyboard Continuously Pressed Warning message Type of signal Cause Action A key on the keyboard Release the key or bolus switch Audible YES KEYBOARD or the bolus switch and press to silence Visual CONTINOUNSLY PRESSED Acoustic tone: were continuously the alarm and to remove the Continuous pressed.

  • Page 70: Technical Alarms

    End of Infusion Alarm message Type of signal Cause Action Infusion finished, the Audible YES Press to acknowledge STOP programmed volume Visual the alarm and press END OF INFUSION to be infused has Acoustic tone: put the “PUMP ON HOLD”. been delivered.
  • Page 71 For pumps with rechargeable battery: Ensure that the Micrel power adaptor is not connected to the Rythmic™ Evolution pump. Open the transparent covers and take the battery cover off. Turn the switch to , as shown in picture 1, the pump will turned OFF and the buzzer will stop. Wait...

  • Page 72: Configuration

    9. Configuration Warning The supervisor of the infusion must decide whether the Configuration chapter should be kept in the present IFU. This chapter refers to pump configurations, which allows the pump to be customised to user and/ or patient specificities and must be manipulated by the clinician only. 9.1 Definitions A Keep venous Open rate can be set to continue the infusion and maintain the venous access after the completion of the delivery of the programmed volume to be infused.

  • Page 73: Configuration Menu

    Note: If the set had been primed manually, choose Warning or No warning. Refer to Chapter 9, paragraph 9.2 "Configuration Menu ". Detailed procedure for priming the line is displayed in Chapter 6, paragraph 6.1 "Priming the Administration set line". Occlusion pressure level The occlusion pressure level can be set in three levels: Low, Middle or High.
  • Page 74 Description How to select values Your choice Language Use the key to select the language and press selection Time Use the keys to adjust the time and press Press to scroll down to the next parameter or use the Date soft keys to adjust the date and press Days of operation Displays the number of full days of operation.
  • Page 75 Description How to select values Your choice Use the keys to set the bolus rate from 50.0 ml/h Bolus rate to 100 ml/h . Press Use the key to select  to enable or  to disable this Keep Vein Open function.

  • Page 76: Accessories And Disposables

    In this section you will find details for all Rythmic™ accessories dedicated to the Rythmic™ Evolution range. Warning Only accessories supplied from Micrel shall be used with the pump. Use of non-specified accessories may impair the operation of the pump and could result to patient death or serious injury.

  • Page 77: Compatible Disposables

    The alkaline battery must be in good condition as it assures continuation of infusion, in case of Mains power failure. The use of the Micrel power adaptor does not inhibit the power of the alkaline battery and will not cancel any battery related warning or alarms. Micrel power adaptor is recommended to extend the life of internal battery and avoid battery alarms at night.
  • Page 78 Mini Rythmic™ Rythmic™ Not for Code Description Rythmic™ Evolution Evolution IV use Evolution Organiser Complete set with Y connector. When the sec- Y full set ondary line at administration sets with Y con- 160ml nection is not used, replace the cap present in KM1.EE.150.x Y connector with a closed cap.

  • Page 79: Using Ip Pack

    Mini Rythmic™ Rythmic™ Not for Code Description Rythmic™ Evolution Evolution IV use Evolution Organiser Yellow Full set A Full set with yellow stripped tubing and 160ml 160ml bag. KM1.EE.161.x Yellow Mini Full set 100ml A Mini Full set with yellow stripped tubing. KE1.EE.167.x Yellow Full set A Full set with yellow stripped tubing and 200ml...
  • Page 80 IP Connect Pack battery. Caution • Prior to using the IP Connect Pack accessory for the first time, use the Micrel power adaptor to fully charge the internal rechargeable battery. • Always keep the internal battery (9V alkaline or rechargeable) inside the pump while...

  • Page 81: Using Carrying Bag And Carrying Belt

    10.5 Using carrying bag and carrying belt. Warning • Ensure that the spike connector is properly attached to the external medication container. Spike detachment from the external medication container could result in under or non-delivery of medication. • When rigid - non collapsible external medication containers (e.g. glass bottles, hard plastic bag) are used with a Rythmic™...
  • Page 82 • Open the carrying bag. • Fit the pump with the display visible through the clear display window. • Align the set to the back of the pump as shown. Ensure that the extension lines are not trapped in the bag. •...

  • Page 83: Using Iv Pole Clamp

    • The IV pole clamp provides a location to store the Micrel Power Adaptor when not in use. The pump can be securely lock to the pole clamp. • To unlock the pump from the pole clamp push the...

  • Page 84: Accessories

    10.7 Accessories A comprehensive list of accessories for the Rythmic™ Evolution pumps is included in the Product Catalogue. This can be ordered from Micrel Medical Devices, or authorized distributor. Indicative list of accessories for Rythmic™ Evolution pumps Code Description KP5.04.271.x IP Connect Pack with power adaptor KP5.04.250.x...

  • Page 85: Precautions & Maintenance

    Contact your healthcare professional regarding any required service. All servicing should be performed by a qualified service engineer with reference to the MICREL Service Manual for this product. A comprehensive service manual containing circuit descriptions, servicing and testing information is available for this unit. It can be ordered from Micrel Medical Devices or Micrel Medical Devices authorized distributor.

  • Page 86: Cleaning Procedure For Pump

    11.2.1 Cleaning procedure for pump To insure that the equipment remains in good operating condition, it is important to keep it clean. Clean the pump periodically following the below described procedure. 1. Wear a new pair of protective sulphur free gloves and eye protection if splashing is likely to occur.
  • Page 87 • The use of non reccomended cleaning solutions and disinfectants and the failure to follow Micrel cleaning and disinfection procedure may result in product damage. • To avoid pump damage, cleaning / disinfectant solutions must be used according to the below table and manufacturer reccommendations.

  • Page 88: Cleaning And Disinfection Procedure For Accessories

    3. Do not clean the area under the battery cover for IP Connect Pack, inside of the connector at the end of the cable for both IP Connect Pack and Micrel Power adaptor and the metal parts of the plug.

  • Page 89: Storage

    Caution • The use of non reccomended cleaning solutions and disinfectants and the failure to follow Micrel cleaning and disinfection procedure may result in product damage. • To avoid equipment damage, cleaning solutions must be used according to the table displayed in paragraph 11.2.2 and manufacturer reccommendations.

  • Page 90: Disposal

    Union should properly dispose the product and the used batteries in an environmentally safe manner using the local collection and recycling points. Contact Micrel's Authorised Distributor or Micrel Customer Support for specific instructions regarding disposal. For consumers outside European Union the disposal or recycling of the used batteries and the product at the end of its useful life should be according to any goverment or local regulations that apply.

  • Page 91: Technical Description

    MICREL Service Manual for this product. A comprehensive service manual containing circuit descriptions, component part list, servicing and testing information is available on request. It can be ordered from Micrel Medical Devices or Micrel Medical Devices authorized distributor. Only trained technicians can perform service / preventive maintenance.

  • Page 92: Specifications

    Internal Battery 36 hours minimum at 25 ml/h Autonomy 28 hours minimum at 100 ml/h External Battery input 6-9 Vdc 500 mA IP Connect Pack IN:100-240 v ~ 50-60 Hz 90 mA Micrel Power Adaptor OUT: 11 Vdc 500 mA...

  • Page 93: Performance & Protocol Parameters

    12.3 Performance & Protocol parameters Volume to be infused 1 to 9999 ml 1 ml increment (inc) 0.1-9999.9 ml 0.1 ml inc. Volume infused 0.1 mg to 9999.9 mg 0.1 mg inc. 0.1 μg to 9999.9 μg 0.1 inc. Programming units ml/h;...

  • Page 94: Historic

    OFF or from 0.1 ml to 60.0 ml 0.1 ml inc. Loading dose 0.1- 999.9 mg 0.1 mg inc. or 0.1- 999.9 μg 0.1 μg inc. OFF or from 0.1 ml to 60 ml 0.1 ml inc. Clinician Override Bolus 0.1- 999.9 mg 0.1 mg inc.

  • Page 95: Performances

    12.5 Performances Memory retention 10 years Expected service life 10 years Maximum over infusion volume under single fault condition 0.5 ml Max Accuracy error (pump speed) under single fault condition ± 5% Rate accuracy in all available range remains within acceptable limits when: temperature range + 5°C to +40°C...

  • Page 96: Safety Features

    • Prime function • Service date warning • Pump configuration • Programming via PC application • Variable alarm tone • With separate Micrel IP Connect Pack infusion can be monitored through internet 12.9 Environmental Conditions Operating Ambient Temperature +5°C - +40°C...

  • Page 97: Symbol Definition

    12.10 Symbol Definition Consult instructions for use Pump is classified as Internally Powered Equipment, Type CF Applied Part as per EN60601-2-24. Protected against splashing fluid (Degree of protection against fluid ingress) when fitted in holster. Device complies with requirements of Medical Device Directive 93/42/EEC.
  • Page 98 Not for IV use Sterilized using ethylene oxide Non pyrogenic Non-pyrogenic fluid path Date of manufacture Batch code Expiry date Catalogue number Priming volume Temperature limitation for storage and handling...
  • Page 99 Latex free DEHP free U.S. federal law restricts this pump to sale by or on the order of a physician. Aseptic technique required. Bio-hazardous waste. Dispose according to hospital’s protocols. Storage volume Pressure Keep away from sunlight Keep away form rain ON / OFF button ENTER button...
  • Page 100 Soft key function depends on the respective display symbol or label. Purge - Bolus button Start / Stop button Battery level indicator Rythmic™ Evolution supplied from the DC adaptor Rythmic™ Evolution supplied from IP Connect Pack External power adaptor inlet/ RS 232 output IEC 6LR61 Battery type Ι...
  • Page 101 EAN number Do not use Dryer Do not iron Machine wash cold Do not use bleach Dry in the shade Do not wring Serial number with year code. The first 2 digits (YY) represents the production year of the pump.

  • Page 102: Trumpet Curves

    12.11 Trumpet Curves In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual sets cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways: 1) the accuracy of fluid delivery over various time periods is measured (trumpet curves), and 2) the delay in onset of fluid flow when infusion commences (start-up curves).
  • Page 103 Start-up Curve @ 1.0 ml/h Trumpet Curve @ 1.0 ml/h...

  • Page 104: Operating Precautions

    12.12 Operating Precautions A comprehensive service manual containing circuit descriptions, servicing and testing information is available for this unit. It can be ordered from Micrel Medical Devices or Micrel Medical Devices authorised distributor. According to EN60601-2-24 , this pump is protected against the effects of external interference and is designed to fail-safe if unreasonable levels of interference are encountered.
  • Page 105 must be shielded and its ability to function properly must be confirmed following treatment. Magnetic fields produced by magnetic resonance imaging (MRI) equipment may adversely affect the operation of the pump. Remove the equipment from the patient and keep it away from the magnetic field.
  • Page 106 HPa susceptible to damage infusion administration set and the pump. Micrel recommends the use of one-way valves or positive pressure infusion devices for multi-line infusions. If there is no one way valve on a gravity infusion line during a multi-line...

  • Page 107: Technical Information

    12.13 Technical Information Electromagnetic Compatibility (EMC) Information Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC). Radio frequency (RF) communications equipment can affect devices such as Rythmic™ Evolution pump. As such, the pump should not be adjacent to these type of equipment. If it is not practical, then observe the pump to make sure it is operating properly after installation.
  • Page 108 Guidance and manufacturer’s declaration: electromagnetic immunity Electromagnetic IEC 60601 Compliance Immunity test environment/ test level level guidance Floors should be wood, concrete or Electrostatic ± 8 kV contact ceramic tile. If floor is ± 6 kV contact discharge (ESD) ± 15 kV air covered with synthetic ±...
  • Page 109 Guidance and manufacturer’s declaration: electromagnetic immunity (cont.) Immunity IEC 60601 Compliance Electromagnetic test test level level environment/guidance Portable and mobile RF communications equipment should 3 Vrms be used no closer to any part of the Conducted 150 kHz to Rythmic™ Evolution pump, including RF IEC 80 MHz 3 Vrms...
  • Page 110 Recommended separation distances between portable and mobile RF communications equipment and the pump. The Rythmic™ Evolution pump is intended for use in an electromagnetic enviroment in which radiated RF disturbances are controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and RF communications equipment and the pump as recommended below, according to the maximum output power of the communications equipment.

  • Page 111: Warranty

    Micrel's expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and post- age prepaid. Loss or damage in return shipment to Micrel shall be at pur- chaser's risk. In no event shall Micrel be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any Micrel product.

  • Page 112: Service Contacts

    Service Contacts For service contact your local Micrel Medical Devices Office or Distributor: Micrel Medical Devices Service Centre Address and Manufacturer according to Medical Device Directive 93/42/EEC: Micrel Medical Devices S.A. 42 Konstantinoupoleos Street GR-19441 Koropi Greece T: +30 210 6032333-4 F: +30 210 6032335 Email: info@micrelmed.com...
  • Page 113 EP0560270, EP0858812, US5980490 Published by Micrel Medical Devices. All possible care has been taken in the preparation of this IFU, but Micrel reserves the right to make changes without notice both to this IFU and to the product which it describes. Micrel seeks to constantly improve its products;...
  • Page 114 www.micrelmed.com...

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