Instructions for Use
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Instructions For Use
This Instructions for Use (IFU) is applicable for the following equipment: Rythmic™ Evolution Mini Rythmic™ Evolution Rythmic™ Evolution Rechargeable Mini Rythmic™ Evolution Rechargeable Rythmic™ Evolution Organiser 500/100 Rythmic™ Evolution Organiser 501/101 Rechargeable
Important Read the entire IFU before operating the Rythmic™ pump. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient.
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 [email protected] or call at +30 210 6032333-4. Pump serial number and software version should be provided at any communication.
Terms used in IFU
!Warning: !Caution:
A warning contains safety information that could result to death or serious injury of patient or operator.
A caution contains information that could result to product damage.
The use of terms "infusion set" and "administration set" are interchangeable with the product name "Rythmic™ Administration Set".
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!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. • The supervisor of the infusion should decide to whom each code and its related actions should be distributed. Incorrect pump programming could result in death or serious injury to the patient. • For those patients who are likely to be adversely affected by unintended operations and failures, including interrupted medication or fluid delivery from the device, close supervision and provision for immediate corrective action should be provided. • The Rythmic™ Evolution is not to be used to deliver blood. • Always inspect the Rythmic™ Evolution pump and its accessories for damaged plastic parts, wires and presence of liquids on its surface, prior to use. If the pump or accessories are dropped, hit, subjected to excessive moisture and/ or beyond temperature limits, immediately take it out of use and return it to authorized service department for inspection. • Infusion system characteristics, such as medication viscosity, catheter size and high delivery rate may affect delivery accuracy. • Only Rythmic™ Administration sets shall be used with the pump. Use of other than Rythmic™ Administration sets may impair the operation of the pump and the accuracy of the infusion. • Always inspect the integrity of the package and the administration set included. • Frozen medication must be thawed at room temperature only. Do not heat medication and administration set in an oven as this may damage the medication, the Rythmic™ Administration set and, cause leakage. • Ensure that the medication administered is indicated for the therapy / route and in accordance to healthcare provider drug / medication protocol and official drug prescribing information. • Ensure that the administration set used to deliver medication is the appropriate one for the specific medication and for the therapy that will be used. • When using the pump for secondary delivery, ensure that the fluids being administered are chemically and physically compatible with each other. • When additional medication is infused through Y connector then over delivery of medication may occur. • Ensure that during delivery the vertical distance between the pump and the injection site should be one meter height maximum. • When using administration set with Y connector ensure a closed cap is used on the Y port when not in use. • 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. Always disconnect the line from patient before priming.
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!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. • Periodically inspect the fluid path for air. If air is seen stop infusion. Air infusion could result to under or non-delivery of medication. • Always inspect for marks, dust, dirt, particles or substance that exist underneath the tubing cover or in the mechanical pumping area before use. • Ensure that the administration set has been properly installed and has not been trapped in transparent covers or in carrying bag, as this may result in under or nondelivery of medication. • Ensure that the release lever is locked in closed position and the tubing cover is closed firmly. If the release lever or the tubing cover become loose, may result in under on non-delivery of medication. • Ensure that the transparent covers are securely closed, to prevent patient access to medication container. • Periodically inspect the fluid container for decreasing volume, inspect the fluid path for kinks, a closed clamp or other upstream obstruction. Upstream occlusions could result in under or non-delivery of medication. • Extra care when using the clinician bolus function. There is no limit, or frequency limit in the use of the override bolus function. Incorrect programming could result in death or serious injury to the patient. • Do not leave the pump unattended while is on Clinician Bolus screen. • Ensure that the spike connector is properly attached to the external medication container. • When rigid- non collapsible external medication containers (e.g. glass bottles, hard plastic bag) are used with a Rythmic™ Spike set, then the air vent on the spike must be opened and the container must be suspended from a pole. • When collapsible external medication container are used in ambulatory infusion (infusion during transportation) ensure that all air has been removed from the external container. If air remains may result in under or non delivery of medications which could result in death or serious injury to the patient. • Ensure that the slide clamp is closed before removing the administration set from the pump, to prevent free flow of medication. • Ensure the battery door has been locked in position. If the battery door becomes loose, then the battery can be removed, which could result in loss of power and nondelivery of medication.
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!Warnings • 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. If the battery is not likely to finish the infusion, replace it before infusion starts. Loss of power may result in nondelivery of medication. • Always inspect the battery compartment for fluid or debris before inserting the batteries. Fluid or debris in the battery compartment may damage the battery terminals and could result in loss of power and non delivery of medication. • Always inspect the battery terminals for debris, grime and damages. If debris or grime exists, clean the terminals according to cleaning instructions. If the debris or grime persists or damage exists remove the device from service. Debris, grime or damage of the battery contacts could result in loss of power and non delivery of medication. • Always have a new battery available for replacement to ensure that the pump can continue its operation for the time specified. • Do not use rechargeable NiCd or NiMH batteries. Do not use carbon zinc batteries. • Only accessories supplied from Micrel shall be used with the pump. Use of nonspecified accessories may impair the operation of the pump. • Ensure that IP Connect Pack if used is ON to supply power to the pump. • Do not pull out the bolus handset at an angle, bolus may be damaged. • Do not remove the bolus handset by pulling the cable, bolus may be damaged. • Do not rotate the bolus connector while removing the bolus handset. • 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. • Do not perform uploading procedure in the presence of a patient. • Do not connect cords supplied from Micrel to other devices rather than the ones that are intended to be used with. • Εxternal power adaptor should be used only indoors. • The external power adaptor should no longer be used if the housing or cable becomes damaged. • Ensure that the external power adaptor is not covered when in operation, is not in close proximity to a heating source and is not exposed to direct sunlight. • The external power adaptor must not come into contact with liquids. • Ensure that the pump is OFF and disconnected from any power supply before commencing the cleaning / disinfection procedure.
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!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. • There are no user serviceable parts or user replaceable parts within the pump, except 9V alkaline disposable battery. • Equipment can be modified as described in service manual by trained service personnel with valid certificate. Appropriate inspection and testing according to service manual, must be conducted to ensure safe use of the equipment. • Do not attempt to service the pump, only qualified service personnel can perform service / preventive maintenance. • During cleaning / disinfection procedure, pay attention that disinfectant solution does not go inside connectors.
!Cautions • Do not use the equipment outside its temperature range. The performance could be affected. • Do not expose the equipment to humidity levels below 15% or above 93% relative humidity. • Do not expose the equipment directly to irritation by therapeutic levels of ionizing radiation because the equipment may be permanently damaged. • Do not operate the equipment in a MRI environment, in the vicinity of high-frequency surgical diathermy equipment, defibrillators, short-wave therapy equipment, strong magnetic fields or Nuclear Magnetic Resonance (NMR) scanners. • Do not expose the equipment to ultrasound energy because it may be permanently damaged. • Do not use the equipment in the presence of flammable anesthetics or explosive gases, to avoid explosion hazard. • Do not expose the equipment to direct sunlight or high temperature or in a closed car in hot days for a long time, since it affects the lifetime of the batteries. • Do not sterilize the equipment under any circumstances.
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!Cautions • Do not clean the equipment using acetone, other plastic solvents or abrasive cleaners as they may damage the equipment. • Do not use hard or pointed objects to clean any part of the pump and its accessories. • Do not spray cleaning fluids directly on the pump and its accessories. • Do not steam autoclave, ethylene oxide sterilise or immerse Rythmic™ Evolution pump and its accessories in any fluid. • Do not use UV radiation to disinfect the pump and its accessories. • Do not use compressed air to dry the pump and its accessories. • Do not mix the disinfectant with any other product or chemical. • Do not immerse the pump in cleaning fluid or water, it is not waterproof and it can cause serious damage to the pump. • Do not store the pump with the battery inside for more than three months. • Do not store the pump with the rechargeable battery depleted. If the pump has to be stored for a long period of time, every three months recharge the battery. • Check that the polarity of the 9V alkaline battery is correctly oriented. • Check that the battery door has been closed correctly, otherwise the transparent covers may not close. • Do not remove the battery while the pump is switched ON as this may damage the pump. • Prior to using IP Connect Pack accessory for the first time, use the power adaptor to fully charge the internal rechargeable battery. • 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 adaptor to fully charge the internal rechargeable battery. • During charging of Rythmic™ Evolution while the pump is switched OFF, there is not any indication of charging progress. • When handling fluid-path connections always follow aseptic technique protocol. • Tighten the luer connectors to prevent leakage. • The administration set is a single use product and must be changed in accordance with the applicable healthcare protocols. • Prior to administering medication under specific delivery conditions, medication stability for time and temperature must be checked. • The use of non reccomended cleaning solutions and disinfectants and the failure to follow Micrel cleaning and disinfection procedure may result in product damage.
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Contents
IFU
1. General Description
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1.1 Introduction 1.2 Pump Layout
10 12
2. Preparation of infusion 2.1 Opening the transparent covers 2.2 Locking the transparent covers
14 14 15
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
16 16 17 18 20 25
3. Pump Functions and Terms
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3.1 Delivery modes 3.2 Definitions of terms used
29 32
4. Actions and codes
35
5. Programming procedure
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5.1 Turn the pump ON/OFF 5.2 Programming the pump 5.2.1 Selecting the delivery mode 5.2.2 Programming with the last used delivery mode 5.2.3 Select programming units 5.2.4 Programming procedure for Continuous+Bolus mode 5.2.5 Programming procedure Continuous mode 5.2.6 Programming procedure Bolus only mode 5.2.7 Programming procedure Automatic Bolus mode 5.2.8 Pre-programming the pump 5.3 Programming through protocol library
36 36 37 37 38 38 40 42 44 46 48
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6. Operation of pump
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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 6.8 Bolus administration 6.9 Answering to Pain level question 6.10 Viewing the remaining volume to be infused and the infusion parameters.
50 52 53 55 56 56 57 58 59 59
7. Historical Data & event log
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7.1 Overview 7.2 Viewing infusion protocol 7.3 Viewing infusion progress and counters 7.3.1 Viewing infusion progress and bolus counters per hour 7.4 Viewing infusion graphs during running/pump on hold 7.5 Infusion events log overview 7.6 Viewing infusion data even after turning off the pump 7.7 Uploading event log to a computer 7.7.1 Uploading detailed event log
60 60 60 61 62 63 63 63 65
8. User Interface Alarm and User Interface Warnings
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8.1 User Interface Warnings 8.2 User Interface Alarms 8.3 Technical alarms
9. Configuration 9.1 Definitions 9.2 Configuration menu
10. Accessories and disposables 10.1 Alkaline Batteries Type for Rythmic™ Evolution 10.2 External Power Adaptor 10.3 Compatible disposables 10.4 Using IP Pack
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66 68 69
71 71 72
75 75 75 76 78
10.5 Using carrying bag and carrying belt. 10.6 Using IV pole clamp. 10.7 Accessories
80 82 83
11. Precautions & Maintenance
84
11.1 11.2 11.3 11.4
84 84 85 85 87 88 89
Routine Maintenance Procedures 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 Storage Disposal
12. Technical Description 12.1 Regulatory Compliance 12.2 Specifications 12.3 Performance & Protocol parameters 12.4 Historic 12.5 Performances 12.6 User Interface Alarms & Warnings 12.7 Safety features 12.8 Miscellaneous 12.9 Environmental Conditions 12.10 Symbol Definition 12.11 Trumpet Curves 12.12 Operating Precautions 12.13 Technical Information
90 90 91 92 93 94 94 95 95 95 96 101 103 106
Warranty
110
Service Contacts
111
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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. The Rythmic™ pump has been specially designed for ambulatory use, but can also be used bedside. The pump can be powered using battery for full portable use but also can be plugged to the mains. The Rythmic™ pump is a safe pump that incorporates the latest features for medication error prevention and also has lockable covers to achieve drug protection for patient. Rythmic™ Evolution pumps are available in blue color coded, in yellow color coded and in green color coded, in order to be used for certain therapies according to your physician’s or healthcare professional’s instructions.
volution range Please, read the following instructions carefully before using this device. Rythmic™ Evolution pump is to be used by qualified personnel who have the qualifications required for medical application and act according to these instructions for use. Infusions must be supervised by clinicians.
Intended use Rythmic™ Evolution pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity /surgical wound site), epidural space, or subarachnoid space infusion.
Contraindications of use Rythmic™ Evolution pumps are not to be used for delivery of blood and insulin.
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When unpacking, check that the system is complete and undamaged. Systems include the below:
ITEM
Rythmic™ Rythmic™ Evolution Rythmic™ Rythmic™ Evolution Mini Mini Rechargeable & Rythmic™ Evolution Evolution & Evolution Rythmic™ Organiser Evolution Organiser Evolution Evolution Rechargeable 501 Organiser 500 Organiser 100 101
Protective Packaging
✓
✓
✓
✓
✓
✓
Instructions for Use
✓
✓
✓
✓
✓
✓
Short instructions for Use
✓
✓
✓
✓
✓
✓
Carrying Bag
✓
✓
✓
✓
Carrying Belt Bolus Handset
✓ ✓
✓
✓
Power Adaptor 9V Alkaline battery
✓
✓
✓
Keys for transparent covers
2
3
2
✓ ✓
✓
✓
✓
✓
✓
2
2
2
!Warning Always inspect the Rythmic™ Evolution pump and its accessories for damaged plastic parts, wires and presence of liquids on its surface, prior to use. If the pump or accessories are dropped, hit, subjected to excessive moisture and/ or beyond temperature limits, immediately take it out of use and return it to authorized service department for inspection. Keep the original packaging for further storage or transportation.
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1.2 Pump Layout Mini
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Transparent cover
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Tubing cover Tubing cover release lever Opening system Injection / filling port Reservoir and tubing Battery cover RS232 port – computer port
Bag Hook Carrying Handle 11 Bolus handset port
Organiser 12
12 Door hood
CONTROLS AND DISPLAY
On/Off key Purge/Bolus key
Soft keys
function depends on the respective display symbol or label
Start / Stop key Enter key
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. Scroll down through pump menu, confirms a programmed value or selected option. Enters codes, sets value during programming, silence the audible alarm for one hour, answer questions on the pump screen, navigates through pump history and protocol. Starts and stops infusion, by pressing the button twice quickly.
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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.
Insert the key and turn gently clockwise in the orientation shown to open the transparent cover.
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Organiser 500/501
Organiser 100/101
Press the knob and pull the cover using the finger grip to open the cover. If the pump is locked insert the key and gently turn it anti clockwise in the direction shown to unlock the push button.
Lift the lever to open the cover. If the pump is locked, insert the key and turn gently anticlockwise in the orientation shown to unlock the lever and lift to open the transparent cover.
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.
2.2 Locking the transparent covers For Rythmic™ Evolution Organisers: Close the transparent covers and turn the key clockwise. Remove the key. For Rythmic™ Evolution: Close the transparent covers. The Rythmic™ Evolution pump is now locked. For Mini Rythmic™ Evolution: Remove the permanent key and close the transparent covers. The Mini Rythmic™ Evolution pump is now locked. 15
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. If the battery is not likely to finish the infusion, replace it before infusion starts. Loss of power may result in non-delivery of medication which could result in death or serious injury to patient. • Always have a new battery available for replacement to ensure that the pump can continue its operation for the time specified. Loss of power may result in non-delivery of medication which could result in death or serious injury to patient. • Ensure the battery door has been locked in position. If the battery door becomes loose, then the battery can be removed, which could result in loss of power and non-delivery of medication which could result in death or serious injury to patient. • Always inspect the battery compartment for fluid or debris before inserting the batteries. Fluid or debris in the battery compartment may damage the battery terminals and could result in loss of power and non delivery of medication. • Always inspect the battery terminals for debris, grime and damages. If debris or grime exists, clean the terminals according to cleaning instructions. If the debris or grime persists or damage exists remove the device from service. Debris, grime or damage of the battery contacts could result in loss of power and non delivery of medication. To access the battery please follow the below procedure: - Verify that the pump is switched OFF. - Place the pump on a table, with the front panel facing downwards. - Open the transparent covers as described in chapter 2, paragraph 2.1 "Opening the transparent covers".
IEC 6LR61
Slide the battery compartment lid in the direction of the arrow marked BATT.
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IEC 6LR61
Insert the batteries within the compartment, observing the correct polarity as shown by the illustration within the battery compartment.
Slide the lid back in place.
!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. • Do not store the pump with the battery inside for more than three months.
2.3.2 For pumps with rechargeable battery Applies to models: Rythmic™ Evolution Rechargeable, Mini Rythmic™ Evolution Rechargeable, Rythmic™ Evolution Organiser 501/101.
!Warning Ensure that the remaining battery power is enough for the infusion that is going to start. If the rechargeable battery is not likely to finish the infusion, charge it before infusion starts. Loss of power may result in non-delivery of medication which could result in death or serious injury to patient. The pump has built in a Lithium Polymer rechargeable battery.
!Caution
• Prior to using pump with rechargeable battery or IP Connect Pack accessory for the first time, use the power adaptor to fully charge the internal rechargeable battery for 3 hours. • During charging of Rythmic™ Evolution while the pump is switched OFF, there is not any indication of charging progress. • Do not turn the switch to position while the pump is switched ON, as this may damage the pump.
• Do not store the pump with the rechargeable battery depleted. If the pump is to be stored for a long period of time, every three months recharge the battery by connecting the pump to a power adaptor connected to mains, for 1 hour to maintain battery’s good condition and prolong battery’s life time. 17
Pump can also be supplied with power using accessory external power supply and /or IP Connect Pack. In every case the presence of a battery (alkaline or rechargeable) is needed. Please refer to chapter 10, paragraph 10.2 and 10.4 for further details.
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. Micrel power adaptor will charge the built in Lithium Polymer battery while powering the pump at the same time. Charge the battery at least 3 hours, using the power adaptor, when Low or Dead battery signal is displayed on the screen. PGM 11 NOV 2014 11:45 PUMP ON HOLD HIS TORY
PROGRAM
PROTOCOL
When the battery is fully charged the battery sign on the top right corner on the screen will be full.
There is no danger of overcharging the battery. The charging cycle is an automatic function performed by special circuit inside the pump. The power adaptor can be used as frequently, and for as much time as needed for bedside use. Care should be taken to fully charge the battery before portable use. After full 3 hours charging, the pump has nominal autonomy for portable use. Be aware that the nominal charging capacity of Lithium Polymer batteries decreases along with the time and the number of recharging cycles. After 300 charge / discharge cycles, Lithium Polymer battery capacity is reduced by more than 30%.
2.4 Pre-Use checklist
!Warning Always inspect the Rythmic™ Evolution pump and its accessories for damaged plastic parts, wires and presence of liquids on its surface, prior to use. If the pump or accessories are dropped, hit, subjected to excessive moisture and/ or beyond temperature limits, immediately take it out of use and return it to authorized service department for inspection.
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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) : …………………...…….
Visual inspection for
Pass
Fail
Pass
Fail
Absence of impact marks / broken covers / damaged wires Sufficient legibility of all labels Absence of dust, dirt, particles or substances underneath the tubing cover Absence of liquid ingression / battery compartment Absence of debris, grime or damage of battery terminals
Functional test Locking system operating properly
Action
Result
Turn the pump ON and verify that buzzer functions properly.
An acoustic tone will sound twice.
Check display during power ON.
No missing dots on dark display. Backlight turns ON.
Check for correct date / time.
Actual date / time.
Enter the new bag code, enter 1ml as volume to be infused and then “DOOR IS OPEN” alarm should press to reach “PUMP ON appear. Press to silent the HOLD” screen. Press to acoustic tone. prime (without administration set inside). “DOOR IS OPEN” alarm should Press to start infusion appear. Press to silent the (without administration set inside). acoustic tone. Connect power adaptor to Mains and to Rythmic™ Evolution.
Mains indicator appear.
should
While power adaptor is connected “BATTERY NEEDED AS BACK UP” to the Rythmic™ Evolution remove message should appear and infusion should not start. disposable alkaline battery and start infusion. Test result : Test performed by : Department: ……………………….
Name: …………………………………………….
If the device fails to perform as described in one or more of the above tests, pump and its accessories should be immediately taken out of use and inspected by authorized service personnel to ensure their proper function prior to use. 19