Graseby Instruction Manuals
Contents
1. foe i Y Graseby Instruction Manuals This publication has been compiled and approved by Graseby Medical Ltd for use with their respective products It is supplied in this format to permit users to access the text and illustrations for their own use e g training and educational purposes Users of the equipment must ensure that they have read and understood the contents of the complete manual including the warnings and cautions and have been trained in the correct use of the product Graseby Medical Ltd cannot be held responsible for the accuracy and any resulting incident arising from information that has been extracted from this manual and compiled into the users documentation These manuals are subject to revision and it is the users responsibility to ensure that the correct version of manual text illustration is used in conjunction with the equipment ACCEPT REJECT GRASEBY Graseby 3400 Syringe Pump Instruction Manual Published by Graseby Medical Limited All possible care has been taken in the preparation of this publication but Graseby Medical Limited accepts no liability for any inaccuracies that may be found Graseby Medical reserves the right to make changes without notice both to this publication and to the product which it describes Graseby Medical seek to constantly improve their products therefore the specification of the 3400 pump is subject to change Copyright 2002 Graseby Medical Limite2. Syringe pump Storage conditions 40 to 70 C 30 to 90 Rh 700 to 1060 hPa Operating conditions 5 to 40 C 30 to 75 Rh 700 to 1060 hPa As factory set the pump gives an occlusion alarm if the force on the syringe plunger is between 5 7 and 6 2 kg This force can be adjusted refer to the Service Manual Page 25 Anaesthesia Syringe pump Page 26 Graseby 3400 For further information please contact your local distributor or Graseby Medical direct on 44 0 1923 246434 GRASEBY Graseby Medical Ltd Colonial Way Watford Herts UK WD24 4LG Telephone 44 0 1923 246434 Facsimile 44 0 1923 231595 http www graseby co uk Part No 0132 0044 K August 2002 2002 Graseby Medical Ltd smiths Smiths Medical A part of Smiths Group plc
3. WARNING This equipment is not suitable for use in the presence of flammable anaesthetics oxygen enriched or explosive atmospheres The use of the device in such atmospheres may lead to explosion or fire 4 WARNING To avoid possible malfunction of the pump do not expose the pump to X rays gamma rays or ionizing radiation or to the RF interference or strong electric magnetic fields emitted for example by diathermy equipment or mobile telephones If the pump is used in the presence of or in combination with Magnetic Resonance Imaging MRI machines it must be protected from the magnetic field emitted by such equipment Malfunction of the pump can cause incorrect infusion or loss of infusion resulting in patient injury or death 5 WARNING Operation of the pump outside the temperature limits defined in the specification may result in erroneous operation Ensure that the temperature is within the specified limits Failure to do so may result in patient injury or user injury 6 WARNING In order to ensure that the intended infusion is performed data must be entered correctly Likewise before confirming any displayed data the user should ensure that it is correct Failure to do so may result in compromised function of the product patient injury or user injury 7 WARNING Failure to respond promptly to an alarm may result in patient injury or death 8 WARNING Failure to follow the Service Manual s maintenance schedule recommendations may
4. it should where possible not be mounted directly underneath the fluid bag s This is to minimise the possible risk of damage to the pump from fluid ingress should the bag rupture or leak during use U S A and Federal law in the U S A and Canada restricts this device to sale by or on the order of a Canada licensed Medical Practioner Graseby 3400 iii Aneasthesia syringe pump iv Graseby 3400 Anaesthesia Syringe pump Contents Page INtFOCUCTION cc cece eeseneeee ee een sneeeee eee enaneeeeeee een sneeeeeeeeeesseeeeeeeeeesneeeeenneees 2 FO GLUNCS oido tase cae e teases E EEA 3 1 Switching OM sanviccesccccccstieiccc ct ccscceeceepeteceececsteeeenceeusnseeeetsesizsenee 4 2 Loading the SYSinGe sccccceeeeeeeceeeeeeeneneeseeeeeeeneeseeeeeesnenaees 5 3 Setting the infusion rate cceecessseeeeeeeeeeeeeeeeeeeeeeeeeeneeeeenes 7 4 Giving a bolus infusion sssssnssssunennnnnnnnenunnnnnunnnnnnnnnnnnnnnnnna 9 5 Setting the hands free bolus preset nsssssesssnnrsnuunnnnnnnnnnennna 9 6 Starting the infusion ccceseeeeeeeeeeeeeeeeeeeeeeeeeeseeseeeeeeeeenneeeeees 9 7 Usingthetotaliser snnssunnneennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnna 10 8 Stopping the Infusion cceeccesseeeeeseeeeeeeeeeeeeseeeeeseeeeeeneeees 10 9 Switching Off oiccesscccccsteescsitce ceeteeeiccsceceeestee cessccens vacddeeeteceeesedents 10 10 ALANIS reso 11 11 Battery operation ssssssssse
5. menu key followed by the desired preset level using the numeric keypad The bolus p350mmuHg using a BD 50ml syringe 350mmHg using a BD 50ml syringe reset is then confirmed by pressing the ENTER menu key The pump will then prompt the user to deliver the hands free bolus by pressing the BOLUS key again If the user does not wish to deliver the set hands free bolus at this time simply ignore the PRESS AGAIN screen message which will disappear after 10 seconds Press START to begin the infusion at the set infusion rate The make and size of the syringe will be displayed briefly followed by the infusion rate Check that the syringe size corresponds with that on the display During the infusion the green start lamp will flash and the pump running indicator arrows on the display will flash In addition the word INFUSING will flash in the display If anything occurs to disrupt the infusion the pump will alarm See section 10 Alarms To change the infusion rate without stopping the infusion see section 3 3 Adjusting the infusion rate whilst infusing WARNING To avoid over or under infusion always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion Failure to do so may result in an inaccurate delivery of medication resulting in patient injury or death Page 9 Anaesthesia Syringe pump 7 Using the totalizer 8 Stopping the infusion 9 Switchi
6. of all air bubbles before administering any medication The pump provides a purge facility to assist with this process The presence of air within the medication can result in complications leading to patient injury or death WARNING To avoid syphoning of the syringe contents free flow ensure that the syringe is correctly loaded into the pump that the syringe plunger is properly engaged by the pump s actuator and that the pump is placed not more than 80cm above the infusion site Syphoning can result in over infusion leading to patient injury or death WARNING To avoid over infusion do not purge the infusion line when the administration set is connected to the patient Over infusion of medication can result in patient injury or death WARNING To avoid the pump becoming detached from an IV pole always make sure that the pump is securely fixed to the pole Always check the security and stability of the assembly with the pump mounted If no IV pole is used make sure that the pump is completely stable on a horizontal surface Failure to observe this warning may cause damage to the 3400 Syringe pump and harm the operator or the patient As a result the operator or patient may suffer direct injury or the 3400 Syringe pump may fail to operate correctly leading to patient injury or death Graseby 3400 Aneasthesia_ syringe pump 22 WARNING Following a significant liquid spill onto the pump it should be wiped dry and inspected by servic
7. rate If the memorised rate is not required it can be altered by pressing the numeric keys to the right of the display To facilitate ease of setting up the keys are arranged in the same format as an electronic calculator The infusion rate can be set to between 0 1 ml hr and 400 0 ml hr in steps of 0 1ml hr For example to set an infusion rate of 132 5 ml hr press 0090 0 Changing the infusion units If the mass units dose rate calculator has been selected in the configuration program the UNITS menu bar will be displayed To change the infusion units press the UNITS menu key until the desired infusion units are shown on the screen The infusion rate can then be entered with the numeric keypad Press ENTER to confirm the choice of infusion units The pump will then ask for the patient weight and or drug concentration The values for the patient weight and or drug concentration are entered via the numeric keypad and confirmed with the ENTER menu key After entering the drug concentration the END OF MENU PRESS START TO RUN screen is shown If the ENTER key is pressed the pump will display the infusion rate in mass units The ml hr infusion rate will be shown in brackets Press the START key to commence the infusion Following the start of an infusion the option to change the units will be disabled until the pump is turned off The UNITS key will be removed from the menu bar Page 7 Anaesthesia Syringe pump 3 3 Adjusting the infus
8. s it should where possible not be mounted directly underneath the fluid bag s This is to minimise the possible risk of damage to the pump from fluid ingress should the bag rupture or leak during use WARNING To avoid the pump becoming detached from an IV pole always make sure that the pump is securely fixed to the pole Always check the security and stability of the assembly with the pump mounted If no IV pole is used make sure that the pump is completely stable on a horizontal surface Failure to observe this warning may cause damage to the 3400 syringe pump and harm the operator or the patient As a result the operator or patient may suffer direct injury or the 3400 syringe pump may fail to operate correctly leading to patient injury or death WARNING Following a significant liquid spill onto the pump it should be wiped dry and inspected by service personnel before being returned to service Failure to do so may result in compromised functioning of the pump leading to patient or user injury or death 13 Cleaning and maintenance Page 20 Cleaning The pump may be decontaminated by wiping it with a mild disinfectant solution For example the disinfectant solution may be made by using sodiudhypochlorite diluted with water to give a solution of 0 1 available chlorine The chlorine concentration will be stated on the product label The solution must be freshly made and used within 24 hours of preparation WARNING Followi
9. whilst the pump is infusing Similarly the bolus infusion rate can be adjusted from 0 1 to 1200 ml hr in steps of 0 1 ml hr A dose rate calculation is also possible allowing the infusion rate to be programmed ina range of units including ml hr mg kg hr mg kg min mg kg hr mg kg min mg hr and mg hr A handsfree preset bolus allows a predetermined bolus to be set and delivered allowing the user to concentrate on the patient s response to the medication during the bolus infusion The pump keeps a running total of the volume of liquid infused even when an infusion is stopped and restarted Safety features have been built into the pump and its software The pump carries out self testing routines every time it is switched on Users are warned of such incidents as occlusion or power failure by both visible and audible alarms The pump can be run from AC mains power recommended or from internal rechargeable batteries which give more than ten hours of use All the controls are clear and easy to use The pump incorporates a graphic liquid crystal display that provides the user with a constant indication of the pump s operation Graseby 3400 Anaesthesia Syringe pump Features Designed in consultation with users the main features of the pump are 0 1 to 1200 0ml hr infusion rate Dose rate calculator Hands Free bolus induction preset Accepts 5 to 60ml syringes from all major brands RS232 Serial link for remote m
10. 10 5 10 5 1 10 5 2 Occlusion OCCLUSION ALARM TYPE Pulsing loud alarm silenceable CAUSE There is a pressure buildup on the syringe plunger clamp probably because of a blocked infusion line The infusion has stopped ACTION Silence the alarm WARNING If an occlusion alarm occurs immediately clamp the line to eliminate the possibility of a bolus being delivered to the patient Then inspect the fluid pathway for kinks clogged catheter etc in order to remove the occlusion prior to restarting the infusion An unintentional bolus of medication can result in patient injury or death To remove the pressure swing the syringe plunger clamp away from the body of the pump and slide to the right Then deal with the occlusion Reposition the plunger clamp Ifthe START key is pressed before the plunger has been opened the pump will not run and the message RELEASE CLAMP will be displayed briefly Restart the infusion as described in section 6 Occlusion sensing system The pump has asensitive internal occlusion pressure detector which detects the pressure build up on the syringe plunger an occlusion is usually caused by a blocked infusion line The pressure at which the pump s occlusion alarm activates is adjustable from 1 85 kg to 7 42 kg 250 mmHg to 1000 mmHg The factory set occlusion pressure is between 5 7 kg and 6 2 kg 767 and 834 mmHg respectfully for a perfect BD 60 ml syringe Time to alarm following occ
11. ault then it must be referred to a suitably qualified engineer or returned to Graseby Medical in order to have the fault rectified ACTION Make a note of the fault code number and switch the pump off The Technical Service Manual part number 00SM 0132 gives further iinformation on the pump s fault codes When the pump is switched on but not connected to the AC power supply it will if the batteries are charged operate as if connected to the AC power except that the AC power lamp will not be illuminated and the following message will be displayed during operation ON BATTERY a B will be shown within the pump running indicator arrow on the right of the display the low battery alarm is operative section 10 11 the batteries will be fully charged if the pump has been connected to mains power for at least 14 hours When fully charged the batteries will power the pump for more than 10 hours WARNING Correct management of battery charging is essential to ensure that the pump can operate on batteries for the time specified Failure to do so may lead to impaired functioning of the pump resulting in patient injury or death Page 19 Anaesthesia Syringe pump 12 Positioning the pump The pump should be positioned and operated horizontally It may be placed on a flat stable surface or mounted on a vertical IV pole or rail using the pole clamp CAUTION If the pump is used in close proximity to a fluid bag
12. d No part of this publication may be reproduced transmitted transcribed or stored in a retrieval system or translated into any human or computer language in any form or by any means without the prior permission of Graseby Medical Limited GRASEBY MEDICAL LIMITED Colonial Way Watford Hertfordshire United Kingdom WD244LG TELEPHONE 44 0 1923 246434 FAX 44 0 1923 231595 www graseby co uk REGISTERED IN ENGLAND COMPANY No 995550 Trademarks and acknowledgements Graseby Smiths and Flo Safer are all trademarks of Smiths Group plc All other trademarks are acknowledged as the property of their respective owners Aneasthesia_ syringe pump Warnings Warnings tell you about dangerous conditions that could lead to death or serious injury to the user or patient that can occur if you do not obey all of the instructions in this manual 1 WARNING To avoid over or under infusion always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion Failure to do so may result in an inaccurate delivery of medication resulting in patient injury or death 2 WARNING To avoid incorrect or inappropriate configuration of the pump the Configuration menu must only be selected by qualified persons or authorised personnel Incorrect pump configuration could lead to inappropriate infusion resulting in patient injury or death 3
13. e personnel before being returned to service Failure to do so may result in compromised functioning of the pump leading to patient or user injury or death 23 WARNING When using a syringe smaller than 50 60 ml the occlusion pressure will increase as the diameter of the syringe decreases i e the smaller the syringe the higher the pressure Cautions Cautions tell you about dangerous conditions that can occur and cause damage to the pump if you do not obey all of the instructions in this manual 1 CAUTION Refer all service repair and calibrations only to qualified technical personnel Unauthorised modifications to the pump must not be carried out 2 CAUTION When turning the pump on if screens similar to those illustrated are not displayed do not use the pump Send the pump to a suitably qualified engineer or return it to Graseby Medical in order to have the fault rectified 3 CAUTION Do not use cleaning and disinfecting agents other than the approved ones specified here 4 CAUTION The pump must not be immersed in any liquids or exposed to strong organic solvents Wipe off spills immediately and do not allow fluid or residues to remain on the pump Additionally the pump is not designed to be autoclaved steam sterilised ETO sterilised or subjected to temperatures in excess of 45 C 113 F Failure to observe this caution may cause serious damage to the pump 5 CAUTION If the pump is used in close proximity to a fluid bag s
14. e syringe trough Syringe size is too small or too large ACTION Ensure the syringe size is appropriate i e 5ml 10ml 20ml 30 35ml or 50 60ml Reposition the syringe barrel on the syringe trough Page 12 Graseby 3400 Graseby 3400 10 3 10 4 Rate invalid Anaesthesia Syringe pump RATE max rate allowed xxx x ml hr INVALID ALARM TYPE CAUSE ACTION Review settings 2 second quiet alarm The START button has been pressed with the infusion rate set to 00 0 ml hr or the START button has been pressed with too high an infusion rate set for the syringe size in use see section 3 4 Maximum infusion rates for different syringe sizes or the infusion rate has been set higher than the maximum rate set in the configur ation mode The maximum allowable infusion rate for the syringe size in use will be indicated Set the desired infusion rate within the permissible range then start the infusion as described in section 6 The START button has been pressed with mass units selected e g mg kg hr and without reviewing the patient weight or drug concentration REVIEW SETTINGS ALARMTYPE 2 second quiet alarm CAUSE ACTION Press the ENTER menu key to confirm the patient weight and or drug concentration When the screen message END OF MENU PRESS START TO RUN is displayed the infusion can be commenced as described in section 6 Page 13 Anaesthesia Syringe pump Page 14
15. ensuring all the air 22 is expelled WARNING To avoid patient embolism ensure that the patient tubing is purged of all air bubbles before administering any medication The pump provides a purge facility to assist with this process The presence of air within the medication can result in complications leading to patient injury or death WARNING To avoid over infusion do not purge the infusion line when the administration set is connected to the patient Over infusion of medication can result in patient injury or death Graseby 3400 Page 5 Anaesthesia Syringe pump 2 3 Insert syringe Swing the plunger clamp up and away from the body of the pump until it clicks and then slide the plunger clamp fully to the right Pull the syringe barrel clamp upwards and insert the primed syringe into the syringe trough Ensure at the same time that the ear of the syringe is located in the groove and pushed fully to the left Ensure that the syringe size sensor is resting on the syringe barrel WARNING Use only the syringes and administration sets listed in the Specification at the end of this manual Failure to do so may result in an inaccurate delivery Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used Incorrect function or performance of the pump can cause complications resulting in patient injury or death Lower the barrel clamp onto the syringe Slide the plunger clamp to the left until i
16. g or energy recovery Larger plastic parts are marked with a material identification code to facilitate recycling Important Existing national or local regulations concerning waste disposal must take precedence over this advice Page 23 Anaesthesia Syringe pump 15 Specification Weight Nominal size Flow rate Driveaccuracy Syringe brands AC power supply Battery type Battery life Not exceeding 3 5 kg including batteries and pole clamp 325 mm x 195 mm x 115 mm with pole clamp fitted and plunger clamp closed 50 60ml Syringe 30 35ml Syringe 0 1 to 1200 0 ml hr 0 1 to 600 0 ml hr 20m Syringe 0 1 to 400 0 mli hr 10ml Syringe 0 1 to 200 0 ml hr 5ml Syringe 0 1 to 100 0 ml hr The delivery volume is accurate to within 2 over a complete syringe length excluding the start up time BD PLASTIPAK 5ml 10ml 20ml 30 35ml 50 60ml BRAUN OMNIFIX 5ml 10ml 20ml 30 35ml 50 60ml SHERWOOD MONOJECT 5ml 10ml 20ml 50 60ml TERUMO 5ml 10ml 20ml 30 35ml 50 60ml FRESENIUS INJECTOMAT 50ml only BRAUN PERFUSOR 50ml only optional conversion kit required IMS PUMPJET 30 30ml only prefilled 100 to 240 V at 50 to 60 Hz 40 VA The pump can be internally powered by 3 sealed lead acid Cyclon batteries More than 10 hours when fully charged and under normal conditions Graseby 3400 Page 24 Temperature range Adjustable occlusion Graseby 3400 pressure Anaesthesia
17. have the fault rectified WARNING Failure to use the mains lead clamp means that the pump may be accidentally or erroneously disconnected from the mains Although there is battery backup in case this happens the battery may not be sufficiently charged Consequently there is a risk of the pump not functioning which could lead to patient injury or death WARNING If an occlusion alarm occurs immediately clamp the line to eliminate the possibility of a bolus being delivered to the patient Then inspect the fluid pathway for kinks clogged catheter etc in order to remove the occlusion prior to restarting the infusion An unintentional bolus of medication can result in patient injury or death WARNING Use only the syringes and administration sets listed in the Specification at the end of this manual Failure to do so may result in an inaccurate delivery Graseby Medical does not guarantee performance of the pump if syringes other than those listed are used Incorrect function or performance of the pump can cause complications resulting in patient injury or death WARNING The volume of fluid contained in the connecting tubing is a residual amount and will not be infused Hence this extra volume of fluid must be allowed for when initially filling the syringe and purging the system Under delivery of medication can cause complications resulting in patient injury or death WARNING To avoid patient embolism ensure that the patient tubing is purged
18. ia Syringe pump There are several alarm states each accompanied by a descriptive message on the display an audible alarm and a flashing red alarm light If the pump was infusing at the time of the alarm then the pump will have stopped automatically except for the on battery low battery nearly empty and AC failure alarm To silence the alarm press the ALARM button The following pages give details of the alarm messages and a brief explanation of their meaning When the START button is pressed and a quiet alarm condition is detected a double beep is sounded accompanied by an alarm display for two seconds WARNING Failure to respond prompily to an alarm may result in patient injury or death WARNING It is essential that clinical staff remain within visual and audible range of the pump so that critical alarms can be seen or heard and responded to Page 11 Anaesthesia Syringe pump 10 1 Syringe plunger clamp disengaged CLAMP OPEN ALARMTYPE 2 second quiet alarm CAUSE The syringe plunger clamp has not been correctly located over the syringe plunger The clamp is not correctly placed in the slot in the plunger clamp ACTION Reposition the clamp on the syringe plunger ensuring the plunger cross piece is correctly placed in the slot in the plunger clamp 10 2 Syringe invalid SYRINGE INVALID ALARMTYPE 2 second quiet alarm CAUSE The syringe size sensor does not detect a valid syringe in th
19. instructions on how to use the pump CLASSIFIED BY Underwriters Laboratories Inc WITH RESPECT TO ELECTRIC SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 2601 1 CAN CSA C22 2 No 601 1 M90 The serial RS232 9 pin D connector that is situated on the rear of the pump enables suitable equipment to be connected to the pump for communication purposes To maintain patient safety the external equipment must comply with IEC 601 1UL 2601 1 The communications protocol can be obtained from Graseby Customer Care Note RS232 communications are not available in Australia and some other territories Page 22 Graseby 3400 Graseby 3400 Disposal Anaesthesia Syringe pump When the time comes to dispose of the pump or its accessories do so in the best way to minimise any negative impact on the environment There are three batteries inside the pump that contain harmful lead and sulphuric acid First discharge the batteries by operating the pump then dismantle the pump and remove all three batteries Do not open up the batteries as this will release the acid Do not incinerate them as they may explode Separate them from the everyday waste as indicated by the graphic symbol on the batteries You may be able to use special recycling or disposal schemes To find out about these contact your local waste disposal service Separate any other parts of the equipment where arrangements can be made for their recovery either by recyclin
20. ion only A B will be shown within the pump running indicator arrow on the right of the display CAUSE The pump is operating on its internal batteries ACTION Reconnect to AC power supply if desired Low battery LOW BATTERY ALARM TYPE CAUSE ACTION Intermittent quiet alarm not silenceable The pump is operating on its internal batteries but it may not be possible for the infusion to continue much longer Reconnect to AC power supply immediately Serial RS232 communications failure COMMS FAILURE ALARM TYPE CAUSE ACTION Continuous loud alarm silenceable The RS232 connection has been disrupted Check the serial interface lead connections and also check the PC pump controlling software If the alarm condition is still unresolved Contact the software publisher Graseby Medical or a qualified technician RS232 communications are not available in Australia and some other territories Graseby 3400 11 Battery operation Graseby 3400 10 14 Anaesthesia Syringe pump Fault mode FAULT 46 ALARM TYPE Continuous loud alarm not silenceable CAUSE There is a fault with the pump WARNING Do not use a faulty pump If the pump develops a fault then an alarm will sound the display will indicate a FAULT condition and the pump will fail to infuse Incorrect performance of the pump can cause complications resulting in patient injury or death If the pump develops a f
21. ion rate whilst infusing The infusion rate can be adjusted without stopping the infusion to allow titration of the drug dose to its physiological effect on the patient Whilst infusing press the CHANGE menu key The pump will display and continue to infuse at the set infusion rate The text message NEW RATE 0 0ml hr appears below the current infusion rate If infusion units other than ml hr are used the screen will show the infusion units in use at the time of pressing the CHANGE key eg mg kg hr Enter the desired new infusion rate via the numeric keypad Press START to confirm the new infusion rate The pump s infusion rate will now change to the new setting which will be shown on the LCD screen 3 4 Maximum infusion rates for different syringe sizes The maximum Infusion Rates for the syringe sizes are Syringe Size ml Maximum Infusion Rate ml hr Maintenance Bolus and under computer control 50 60 400 1200 30 35 400 600 20 400 400 10 200 200 5 100 100 The minimum rate is 0 1 ml hr Note the pump can have a maximum allowable infusion rate set via the pump s configuration program If the maximum allowable rate is exceeded an alarm message is shown briefly see section 10 Alarms 3 5 Start up time The time taken for a syringe pump to achieve the set infusion rate is known as the start up time The start up time is dependant on the infusion rate and the syringe size the higher the infusi
22. jury or death If the pump develops a fault then it must be referred to a suitably qualified engineer or returned to Graseby Medical in order to have the fault rectified WARNING Failure to use the mains lead clamp means that the pump may be accidentally or erroneously disconnected from the mains Although there is battery backup in case this happens the battery may not be sufficiently charged Consequently there is a risk of the pump not functioning which could lead to patient injury or death Graseby 3400 Anaesthesia Syringe pump 2 Loadingthe 2 1 Syringe brand syringe When the pump is switched on Section 1 the display will indicate which syringe brand the pump is calibrated for The syringes are disposable and are for single use only Syringe brand Syringe sizes BD PLASTIPAK 5ml 10ml 20ml 30 35ml 50 60ml BRAUN OMNIFIX 5ml 10ml 20ml 30 35ml 50 60ml MONOJECT 5ml 10ml 20ml 50 60ml TERUMO 5ml 10ml 20ml 30 35ml 50 60ml FRESENIUS INJECTOMAT 50ml only BRAUN PERFUSOR 50ml only conversion kit required IMS PUMPJET 30ml only prefilled If a syringe size smaller than 50 60 ml is going to be used for an infusion the following WARNING must be observed WARNING When using a syringe smaller than 50 60 ml the occlusion pressure will increase as the diameter of the syringe decreases i e the smaller the syringe the higher the pressure Prime syringe Fill and prime the syringe and catheter in the normal way
23. lusion The time to alarm following occlusion is due to a number of factors which include the compliance inthe syringe and infusion line and mainly the infusion rate Under normal conditions and using anon compliant infusion line i e a thick walled non flexible line the time to alarm following occlusion at 1 0 ml hr is approximately 27 minutes at an occlusion pressure setting of about 350mmHg using a BD 50ml syringe Graseby 3400 Graseby 3400 10 6 Anaesthesia Syringe pump This time can be further reduced by reducing the internal occlusion pressure Alower pressure will give a shorter time to alarm but there may be anincrease in false alarms The maximum time to alarm following occlusion will occur at the lowest settable infusion rate of 0 1ml hr At rates as low as this the time to alarm is likely to be several hours unless smaller syringe sizes are used The nearly empty alarm system The pump has a unique intelligent nearly empty alarm system One of two messages is displayed This alarm only operates at infusion lt 3 mins to END rates at or below 100 ml hr ALARM TYPE Intermittent quiet alarm CAUSE The syringe is nearly empty there are less than 3 minutes before the syringe enters the KVO mode section 10 7 The pump is continuing to infuse at the set rate ACTION This alarm can be silenced If you wish to continue infusing fill prime and reload the next syringe section 2 2 If not s
24. m silenceable CAUSE Either the syringe is empty and the infusion is complete or there is a pressure build up on the syringe plunger clamp probably because of a blocked infusion line The pump has stopped infusing ACTION Press the alarm silence key to silence the audible alarm Prepare prime and load a new syringe or switch off the pump In the case of an occlusion action is as in section 10 5 Graseby 3400 Anaesthesia Syringe pump 10 9 Not infusing NOT INFUSING ALARM TYPE Intermittent quiet alarm silenceable CAUSE The pump has been switched on but the START button has not been pressed CAUSE The infusion may have been stopped or completed and the user has neglected to press the START button again or switch the pump off ACTION Commence the infusion as described in section 6 or switch the pump off 10 10 AC power failure AC MAINS FAIL ALARM TYPE Intermittent quiet alarm silenceable CAUSE The AC power supply has been interrupted during an infusion The pump will automatically switch to running on its internal batteries A fully charged pump will operate for more than 10 hours ACTION This alarm can be silenced and the pump will continue running on its batteries Reconnect to the AC power as soon as possible Graseby 3400 Page 17 Anaesthesia Syringe pump Page 18 10 11 10 12 10 13 On battery ON BATTERY ALARM TYPE No audible alarm screen indicat
25. n refer to the Graseby Medical Technical Service Manual part number 00SM 0132 For further information contact Graseby Medical Customer Care or your local distributor WARNING Failure to follow the Service Manual s maintenance schedule recommendations may result in compromised function of the product and lead to patient injury or death CAUTION Refer all service repair and calibrations only to qualified technical personnel Unauthorised modifications to the pump must not be carried out A list of Spare parts and accessories is provided in each of the following The Graseby Illustrated Parts Catalogue and Price List part number 0199 0702 The Technical Service Manual part number OOSM 01 32 Page 21 Anaesthesia Syringe pump 14 Standards Insulation The pump is a Class II double insulated device Also classified as Internally Powered Equipment Y Type CF Cardiac Floating insulation on all inputs Safety EN6060 1 EMC EN6060 1 2 Fluid ingress IPX1 protection against drops of water falling vertically Registered design applied for UK PATENT NO 2229497 CE Marking The CE mark demonstrates that the pump conforms to the requirements in 0473 the European Council Directive 93 42 EEC concerning medical devices The number 0473 identifies the Notified Body under which the Quality Systems operated within Graseby Medical Ltd are assessed Refer to the accompanying
26. ng a significant liquid spill onto the pump it should be wiped dry and inspected by service personnel before being returned to service Failure to do so may result in compromised functioning of the pump leading to patient or user injury or death CAUTION Do not use cleaning and disinfecting agents other than the approved ones specified here CAUTION The pump must not be immersed in any liquids or exposed to strong organic solvents Wipe off spills immediately and do not allow fluid or residues to remain on the pump Additionally the pump is not designed to be autoclaved steam sterilised ETO sterilised or subjected to temperatures in excess of 45 C 113 F Failure to observe this caution may cause serious damage to the pump Graseby 3400 Maintenance Spare parts Graseby 3400 Anaesthesia Syringe pump The Department of Health in its publication MDA DB 9503 has recommended that infusion pumps are checked by a qualified technician at regular intervals Graseby Medical supports this policy and recommends that for all our products the functional and safety tests listed in the Technical Manuals are carried out annually Additionally with reference to the Department of Health publication SAB 94 26 July 1994 we recommend that any of our products that have been dropped or subjected to severe fluid spills should be removed from use immediately and checked by a qualified technician For technical and repair informatio
27. ng off Page 10 The totalizer shows how much drug has been infused The totalizer can be accessed when the pump is running or when the pump is stopped Press the TOTAL menu key For a few seconds the display will show TOTAL XXX X ML If the dose rate calculator is in use the totalizer will display the mass of drug infused based on a calculation using the actual volume infused and the current drug concentration It is recommended that the total infused counter is reset when changing the drug concentration to prevent any possibility of misinterpretation of the calculated total mass of drug infused If you wish to reset the totalizer press the RESET totalizer menu key when the total is displayed It is not possible to reset the totalizer without first accessing the display totalizer program The totalizer can only be reset when the pump is stopped Press the STOP button to stop the infusion The yellow stop lamp will illuminate and the pump running indicators in the display will disappear First stop the infusion see section 8 and then press the OFF button to switch the pump off The AC power indicator lamp will remain illuminated if the pump is connected to the AC power and the batteries will continue to be charged Disconnect from the AC power supply if the pump is not going to be used for any length of time the AC power indicator lamp will then extinguish Graseby 3400 10 Alarms Graseby 3400 Quiet alarm Anaesthes
28. on rate the faster the start up time Smaller syringes give better results at any given flow rate Typical start up times for the pump using a 50ml syringe are 3 minutes at 5 ml hr and 15 minutes at 1 ml hr Page 8 Graseby 3400 4 Givinga bolus infusion 5 Setting the hands free bolus preset 6 Starting the infusion Graseby 3400 Anaesthesia Syringe pump Press the BOLUS key the display will show the message PRESS AGAIN together with the bolus infusion rate If the desired bolus infusion rate is shown press the BOLUS key immediately and hold it depressed Whilst running in the bolus mode the alarm lamp and run lamp will flash The display will show the BOLUS sign flashing and the total fluid quantity delivered since the BOLUS button was pressed This total is added to the total infused counter To change the bolus infusion rate press the BOLUS key followed by the RATE menu key The desired bolus rate is then entered via the numeric keypad Press the BOLUS key to confirm the new bolus infusion rate If the hands free bolus preset is enabled in the pump s configuration program the following screen will be shown when the BOLUS key is pressed PRESS AGAIN BOLUS RATE 1200 0 ml hr DOSE RATE The bolus rate is adjusted by pressing the RATE menu key keying in the desired bolus rate with the numeric keypad and pressing the ENTER key to confirm your setting The hands free bolus dose is entered by pressing the DOSE
29. onitoring and control of infusion AC mains and battery powered More than 10 hours battery life Simple menu driven operation Comprehensive safety self check with clear alarm messages Drip proof Syringe type Syringe Syringe Syringe Plunger START button and size barrel size sensor ear clamp and LED ALARM clamp silence Syringe STOP button button Display ear groove and LED Alarm LED 10 0 ml h ENTER LED Bolus button Menu selection Menu Option Keypad Power Power GM0759 A buttons Titles 12 keys ON OFF Figure 1 Front view of the pump Graseby 3400 Page 3 Anaesthesia Syringe pump 1 Switching on Page 4 Connect to AC power For battery operation refer to Section 11 Insert the AC power lead into the rear of the pump Secure the mains lead with the clamp as shown in Figure 2 to prevent it from being accidentally pulled out of the pump Figure2 Mains Lead Clamp The AC power indicator lamp will illuminate when connected to AC power Press the ON key to switch on the pump A brief self test procedure will then be performed during which a bleep will be heard The pump is now in its set up mode ready for an infusion rate to be set WARNING Do not use a faulty pump If the pump develops a fault then an alarm will sound the display will indicate a FAULT condition and the pump will fail to infuse Incorrect performance of the pump can cause complications resulting in patient in
30. result in compromised function of the product and lead to patient injury or death 9 WARNING It is essential that clinical staff remain within visual and audible range of the pump so that critical alarms can be seen or heard and responded to 10 WARNING The user should ensure that the performance offered by the pump is fit for the intended purpose Failure to do so may result in compromised function of the product patient injury or user injury 11 WARNING When the pump is carrying out an infusion to ensure that electrical safety is maintained only items of equipment that conform to EN60950 are to be connected to the RS232 connecior situated at the base of the pump otherwise patient safety may be compromised Graseby 3400 Aneasthesia syringe pump 12 13 14 15 16 17 18 19 20 21 WARNING Correct management of battery charging is essential to ensure that the pump can operate on batteries for the time specified Failure to do so may lead to impaired functioning of the pump resulting in patient injury or death WARNING Do not use a faulty pump If the pump develops a fault then an alarm will sound the display will indicate a FAULT condition and the pump will fail to infuse Incorrect performance of the pump can cause complications resulting in patient injury or death If the pump develops a fault then it must be referred to a suitably qualified engineer or returned to Graseby Medical in order to
31. ssnnunnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn na 19 12 Positioning the pump sssssssssununnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnna 20 13 Cleaning and maintenance cccceeecssseeeeeeeeeeseeeeeeesneeeeeeae 20 14 Standards ois c cee ncvcsccceiveeeeieececteecesacecssnccesesecseectentercceceneessebveveces 22 15 SPOCHICATIONT isione iarna eaa a aai 24 Graseby 3400 Page 1 Anaesthesia Syringe pump Introduction Page 2 Thank you for choosing a Graseby 3400 Anaesthesia syringe pump This Instruction Manual contains important information on operating and looking after your pump So that you are completely familiar with all of the pump s features please take the time to read this manual before switching on the pump It is important that all users of the 3400 have been trained in how to use the pump The pump is a micro computer controlled device developed by Graseby Medical for the administration of sterile liquids This compact robust pump is designed to sit on a table top or to be pole mounted It can be configured to work with one of a range of brands of syringe and the the brand that the pump is presently Configured for is displayed The pump caters for syringe sizes of 5 10 20 30 35 50 and 60 nil the size is automatically sensed and displayed The pump can be set to dispense liquids at maintenance rates of 0 1 to 400 mi hr in steps of 0 1 ml hr The rate is entered via a numeric keypad and can be adjusted
32. t is touching the syringe plunger Lower the clamp until it clicks over the syringe plunger Ensure the plunger cross piece is correctly placed within the slot in the clamp WARNING To avoid over or under infusion always verify that the brand and size of the loaded syringe are the same as the brand and size displayed on the screen before starting an infusion Failure to do so may result in an inaccurate delivery of medication resulting in patient injury or death WARNING To avoid syphoning of the syringe contents free flow ensure that the syringe is correctly loaded into the pump that the syringe plunger is properly engaged by the pump s actuator and that the pump is placed not more than 80cm above the infusion site Syphoning can result in over infusion leading to patient injury or death Check Check Syringe type and size Syringe size sensor corresponds to the type is located on top of syringe and size of the syringe you are using Check Syringe plunger fits into plunger clamp groove when clamp is lowered Check Syringe ear is located in groove Barrel TOTAL GM0760 A Figure 3 Inserting the syringe Page 6 Graseby 3400 3 Setting the infusion rate Graseby 3400 3 1 3 2 1 3 2 2 Anaesthesia Syringe pump Infusion rate memory After switch on the pump will display the infusion rate and units that were memorised since the last time that the pump was used Seiting the infusion
33. top the infusion when the end of infusion alarm sounds section 10 7 10 8 This alarm operates at infusion rates above 100 ml hr or when a syringe is NEARLY EMPTY loaded with approximately 2 5 cm or less syringe plunger travel remaining ALARMTYPE Intermittent quiet alarm CAUSE The syringe is nearly empty The pump is continuing to infuse at the set rate ACTION This alarm can be silenced If you wish to continue infusing fill prime and reload the next syringe section 2 2 If not stop the infusion when the EMPTY OCCLUSION alarm sounds section 10 8 Page 15 Anaesthesia Syringe pump 10 7 10 8 Page 16 Infusion ended KVO mode This alarm only operates at infusion ENDED KVO 5 rates at or below 100 ml hr and follows the lt 3mins to END alarm ALARM TYPE CAUSE ACTION Syringe empty Pulsing loud alarm silenceable The infusion has stopped The pump is running at a rate of 0 5ml hr or less if set rate is less to keep the vein open Press the alarm silence key to silence the audible alarm If you wish to continue the infusion fill prime and reload the next syringe section 2 2 The small amount of drug left in the syringe can be infused at the set infusion rate by stopping and re starting the pump To stop the infusion press STOP Note the KVO mode is not operative when the pump is controlled by an external computer EMPTY OCCLUSION ALARM TYPE Pulsing loud alar
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