Contents Introduction 2 A. About this manual.2 B. Manufacturer s Responsibility.2 C. Warranty 3 D. Unpacking and Accessories.. 3 E. General Safety...3 1.Overview.. 7 2.Operating Principle....7 3.Technical Specifications......8 4.Operation 11 4.1. Stand by and charge.. 11 4.2. Power ON and Self-check.11 4.3. Syringe Installation and Settings.11 4.4. Rate Setting...11 4.5. Volume To Be Infused Setting..12 4.6. Occlusion Pressure Setting...12 4.7. Selection of syringe brands..13 4.8. Fast Infusion..13 4.9. Total Volume..14 4.10. Alarms.14 4.11. Standard RS232 port.15 4.12. Pump Installation..15 5. Troubleshooting..16 6. Maintenance 16 7. Packing List 17 8. Warranty Terms and Conditions..18 1
Introduction A. About This Manual This operator s manual has been prepared to provide information on the correct use of the DIGICARE BIOMEDICAL TECHNOLOGY INC. Digipump SR7 Syringe Infusion Pump. It contains performance specifications and installation, operation and maintenance information. It is intended for trained health care professionals. Follow each chapter in the manual sequentially if the infusion pump is being used for the first time. B. Manufacturer s Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: The equipment is used in accordance with the instructions in this manual. The electrical installation complies with all applicable regulations. Assembly operations, extensions, re -adjustments, or repairs are carried out by personnel authorized by the manufacturer. It is up to the user to ensure that any applicable regulations respecting the installation and operation of the infusion pump be observed. The operator should read this manual carefully and thoroughly before attempting to use the infusion pump. Incorrect operation or failure of the user to maintain the infusion pump in accordance with proper maintenance procedures relieves the manufacturer or his agent from all consequent non -compliance, damage or injury. 2
C. Warranty All products manufactured by Digicare Biomedical Technology Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. The warranty on accessories is ninety (90) days. If an examination by Digicare, discloses such products or component parts be been defective, then our obligation is limited to repair or replacement (at our option). D. Unpacking and Accessories Carefully remove the infusion pump and its accessories form the shipping carton. Save the packing materials in case the infusion pump must be shipped or stored. Ensure your Digipump SR7 has the items listed in the SHIPPING LIST inside the carton. E. General Safety E.1 Indications The Digipump SR7 infusion pump is a device designed for continuous operation. It is intended for use by person s trained in professional health care. The operator must be thoroughly familiar with the instructions in this manual before using the instrument. E.2 Warnings The Digipump SR7 infusion pump was designed and tested accordingly to the EMC Standard IEC601-1-2. However, the operator is responsible to verify if the infusion pump is been affected or affecting others electrical equipment. Equipments like electrocautery and image scanners can generate interference and cause degradation of the Digipump SR7 infusion pump performance. To avoid this situation, it should be installed as far as possible of those equipment. The Digipump SR7 infusion pump is NOT intended to be used during MRI (magnetic resonance imaging). 3
The Digipump SR7 infusion pump is NOT suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. Do not operate this product in the presence of flammable anesthetics. Explosion may result. Follow the instructions on this manual. Set the parameters appropriately and use only perfusor lines specified for the DigiPump SR7. Stop the device immediately in case of any abnormal functioning of the infusion pump. Keep the DigiPump SR7 far, at least 1 meter (3.0 feet) from other generating HF equipments such as electrosurgical unit and others. Before using the infusion pump, make sure the AC voltage at your installation site is correct for the AC rating for the device. If the rating is not correct, do not use the infusion pump and contact Digicare Customer Service for help. Hold on the plug firmly when plugging in or pulling out the power cord. Do not touch the power plug with wet hand. Do not share the same power outlet with other appliances. Do not disassemble the device or modify it. Perform daily check before use. Make sure all functions perform well if the infusion pump is not being in use. The SR7 syringe pump has been calibrated for use with single -use disposable syringes. To ensure correct and accurate ope ration, only use Luer-Lock versions of the syringe brands specified on the pump or described in this manual. Use of non-specified syringes or administration sets may impair the operation of the pump and the accuracy of the infusion. Uncontrolled flow rate may result if the syringe is placed incorrectly in the pump or if it is removed from the pump before the extension line is 4
properly removed from the patient. When combining several apparatus and /or instruments with administration sets and other tubing, like for example a 3 way, the performance of the pump may be impacted and should be monitored closely. The pump must be mounted within 1.0m above or below the patient s heart. Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe. To protect against the introduction of air, the user should regularly monitor the pro gress of the infusion, syringe, extension line and patient connections and follow the priming procedure specified herein. This is a positive pressure device designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system. The pumping pressure alarm system is not designed to provide protection against, or detection of, infiltration conditions that can occur at low pressures. Several alarm conditions detected by this pump will stop the infusion and generate audible and visual alarms. Users must perform regular checks to ensure that the infusion is progressing correctly without alarms. If this instrument is dropped, subjected to excessive moisture, fluid spillage, humidity or high temperature, or otherwise suspected to have been damaged, remove it from use for inspection by a qualified service engineer. When transporting or storing the pump, use original packaging where possible, and verify temperature, humidity and pressure ranges stated in this manual. Electric shock hazard exists if the pump s case is opened o r removed. Refer all servicing to qualified service personnel. 5
When connected to an external power source, a three-wire (Live, Neutral, Ground) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the equipment should be operated only from it s internal battery. After long-term use, the keys in the front panel can become caved in. This can cause errors in the ope ration of the pump. If this happen please call Digicare for service. Use only disposable syringe designated by Digicare. Otherwise inaccurate rate and incomplete infusion may occur. When LOW-BATT alarm is triggered, the pump must be immediately plugged to AC or powered off. Operating the pump in it s internal battery until fully depleted can cause failure and damage to the battery. After pressing FAST key, observe whether flow rate returns to original flow rate programmed. If it keep the same flow rate as the FAST, stop the pump and verify correct operation. Contact Digicare for service. The pump shall be clamped or reliably fastened by the user. It cannot be laid on flat surface or rail to avoid sliding of the pump. Connect the power cable to the pump in shutdown condition. Defective batteries shall be displaced following local environmental protection authority. When connected to an external power source, a three-wire (Live, Neutral, Ground) supply must be used. If the integrity of the external protective conductor in the installation or its arrangement is in doubt, the equipment should be operated only from it s internal battery. This pump belongs to continuous operation device type I equipment with BF isolation. The symbol Indicates type BF equipment. 6
IP grade is IP4 and belongs to water-splashing resistant equipment 1. Overview The SR7 is a constant-volume infusion pump. The advantages of this type of pump are high accuracy, stable flow rate and small amount of liquid used. It is especially suitable for infusion of emergency drugs such as Nipride, Dopamine and antibiotics. The pump can use 13 types of 20ml, 30ml or 50ml disposable syringe. Once the syringe is clamped on the pump, the pump will automatically identify the size of the syringe. In addition, the pump provides alarm functions to guarantee security and reliability of the infusion. 2. Operating principle The SR7 syringe infusion pump is a constant-volume pump. Drug volume output in schedule time will not be influenced by resistance in infusion line. When pressure reaches certain value, an overpressure alarm system set on the pump will trigger a sound and visual alarm and stops infusion. The pump actual output volume is consistent with the programmed volume. When any of the specified syringes is clamped on the pump, an identification system automatically adjust the corresponding rate. Just s et each required parameter, press STA RT key and the pump will begin operation. When the remaining liquid in the syringe reaches approximately 1.5ml, NEA.EMPTY message lights on the pump and intermittent sound alarm is triggered (sound alarm can be turned off by pressing the mute key). When the last 1.5ml liquid is over, EMPTY message lights on the pump and intermittent sound alarm is triggered. At this point the infusion is complete and the pump enters into KVO rate. If the infusion line is obstructed, the OCCLUSION message lights on the 7
pump and intermittent sound alarm is triggered. The pump automatically releases the system pressure. Pressing the Mute key returns the pump to previous infusion state. During operation, if power cord is disconnected, the pump triggers an intermittent sound alarm and light the Battery indicator in the front panel (alarming sound can be eliminated by pressing the Mute key) When the battery is near depleted, the Low Battery alarm triggers an intermittent visual and sound alarm. When the battery is fully depleted, the pump stops operation and alarm sound becomes continuous. 3. Technical Specifications? Flow rate: 20ml syringe: 0.1-399.9ml/h (press, 0.1ml/h increments; press,1ml/h increments ) 30ml syringe: 0.1-600.0ml/h (press, 0.1ml/h increments; press,1ml/h increments ) 50ml syringe: 0.1-1200ml/h (press, 0.1ml/h increments; press,1ml/h increments)? Fast rate: 1200ml/h (50ml syringe) 600ml/h (30ml syringe) 399ml/h (20ml syringe)? Total volume: 0-9999ml (0.1ml increments, above 1000ml 1ml increments)? Programmed volume: 0-9999ml (press, 0.1ml/h increments; press 1ml/h increments)? Accuracy: =±2% ( Drive accuracy ±1%)? OCCLUSION pressure: 40N ± 10N (L) 60N ± 10N (H) 8
? Alarm: near empty (NEA.EMPTY), empty, wrong clamping of syringe, wrong clamping of syringe plunger, malfunction, missing operation after power on, occlusion, total volume equal to preset volume, Low battery, battery depleted, AC power failure.? Power: AC: 115V or 230V, 50/60HZ Internal: DC12V The pump can run continuous ly for 4 hours at the rate of 5ml/h, using internal battery after it is charged for 16 hours.? Operating conditions: temperature: +5 to +40? ; RH: 20% to 90%? Transport and storage conditions: temperature: -40 to +55? ;? Dimensions: 307(L) 135(D) 128(H)mm RH: =95%? NET Weight: 2.1kg? Syringe: total 13 syringe brands can be used (refer to sheet 1) 9
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4. Operation 4.1 Stand by and charge After connecting AC power, the AC indicator is light and the pump battery start to be charged 4.2 Power ON and Self-check To power on, press power key for 2 seconds, the pump do a system check for 3 seconds and is on for operation. Err indication on LED display indicates Pump malfunction. 4.3 Syringe Installation and Settings Connect the extension tube to the syringe with liquid. Remove all air from the infusion liquid and place the syringe flange into pump fixed groove. Press the rocking plate and the advancing head to move and adjust the position of the advancing head. Place the syringe plunger into the advancing head groove. Set all parameters, press FAST key then press and hold the Fast key until the liquid comes out of the scalp needle point. Insert needle tip into vein (artery) of patient and press START key, the pump then start programmed infusion. 4.4 Rate Setting After Power ON the Flow Rate LED display shows 888.8 and it can be set using the 4 digit keys. fast digit setting key, decimal slow digit setting key. 11
Only in STOP mode the flow rate setting is available. After START all rate setting keys are locked. Set the desired Flow Rate and p ress the START infuse the whole liquid in the syringe or press the SELECT key to move to the next parameter. 4.5 Volume To Be Infused Setting Set the desired Volume to Be Infused LED Display by using the 4 digit keys. fast digit setting key, decimal slow digit setting key. Press START to start the programmed infusion or press the SELECT key to move to the next parameter. 4.6 Occlusion Pressure Setting Set Occlusion Pressure limit as high(h) or low(l). Default value is L. OCCL is displayed on the main LED display and L is displayed in the OCCLU.LIMIT display. Pressing slow digit setting key you may set the occlusion pressure limit to H or L. Press START to start the programmed infusion or press the SELECT key to move to the next parameter. 12
4.7 Selection of syringe brands The syringe Brand number is displayed as 10 -. Choose syringe brand listed in table 1 pressing the digit select keys. No. The syringe Brand set is stored and is automatically set as default. Press START to start the programmed infusion. 4.8 Fast Infusion Fast infusion has two modes : Brand -01- Yusheng -02- LD -03- Weigao -04- Xinhua -05- TERUMO (japan) -06- Suyun -07- KDL -08- Shuangge -09- LY -10- B-D -11- JMS -12- Dragon heart -13- Dispo van 4.8.1 Fast volume will not be added into total volume: At STOP condition, press the FAST key twice and hold. The Fast infusion starts and keeps as long as you hold the Fast key pressed. For 50ml syringe, Fast rate is 1200ml/h, for 30ml syringe is 600ml/h and for 20ml syringe is 399ml/h. The Fast rate is displayed in the LED digital display. 4.8.2 Fast Volume is added into Total volume At START condition, press the FAST and TOTAL key simultaneously. The Fast infusion occurs as long as you keep pressing the keys and the display shows the added volume. 13
4.9 Total Volume Press the Total key in STOP or START mode to display the Total Volume injected in the patient. Press Total volume key and mute key simultaneously to reset accumulated total volume to 0. 4.10 Alarms Near empty---when the syringe liquid reaches approximately 1.5ml, near empty alarm is triggered with visual and sound indication (NEA.EMPTY). Empty---when the syringe liquid finish, Empty syringe alarm (EMPTY) is triggered with visual and sound indication. The rate automatically changes to KVO rate 0.5ml/h. Occlusion---when needle tip or extension tube is blocked, the pump triggers an audio and visual alarm. The system pressure is released. If the clamp plate has not been pressed against the syringe or if syringe has been removed during operation, the pump will trigger an audio and visual alarm and will stop. If plunger of syringe has not been inserted into groove of advancing head, after start, the pump will trigger an audio and visual and will stop. Total volume---when total infused volume reaches programmed volume to be infused, the pump will trigger an audio alarm and stop. The LED display flashes the Rate and Total Volume values. To disable the audio alarm press the Mute key. Two minutes later, if no operation happened it will sound again. AC power failure--- if the pump is turned on and it is not connected to the AC power or if the power cord falls off during operation, the pump will trigger an audio and visual alarm. Press Mute to stop the audio alarm. The Battery indicator will stay light indicating the unit is running 14
on battery. Low battery ---when the internal battery voltage is low, the pump will trigger an audio and visual alarm (LOW-BATT). Press Mute to disable the audio alarm. The pump can run for approximately 30 minutes more in the internal battery. Depleted Battery Alarm--- when the battery if fully depleted, the pump will stop running and trigger a continuous audio alarm. No Operation Alarm---After power, if the pump is in the STOP mode and no any operation happens within 2 minutes, the pump triggers an audio alarm. Mute key---except for malfunction, battery depleted and syringe displaced alarm sounds can be cancelled by pressing mute key. Two minutes later, if no operation happened, the alarm will sound again. 4.11 Standard RS232 port The pump has a standard RS232 interface and two -way communication is available. Interface connector is present in the rear panel. Other equipment connected with RS232 interface shall comply with standard IEC60950:1999. 4.12 Pump Installation The pump may be clamped vertical or horizontal on supporting pole or bed level. 15
5. Troubleshooting Failure Possible reasons Action Inaccurate rate Low Battery alarm triggered shortly after startup When start infusion, blood return shows in the infusion line. Unsmooth move of advancing head Syringe flange does not enter into the groove of the syringe stool. Wrong syringe selection The battery was not charged after previous use or pump has not being used for a long time after previous charge Improper use of build-in battery, the battery is damaged. Before inserting the needle tip into vein, mechanism gap was not cancelled by pressing FAST key. Syringe flange does not enter into the groove of the syringe stool. Clamp block is stuck by liquid Re-install the syringe correctly Use syringe recommended in table 1 Recharge battery Replace battery Make sure no air is present in the infusion line. Press FAST key and push the blood back into vein. Re-install the syringe correctly Clean with alcohol 6. Maintenance Two AC fuses are located inside the pump. If the AC indicator does not light when the pump is connected to the AC mains, contact Digicare for technical support. Fuse specification is FAST; 0.5A; 250VAC; (5 20mm). 16
Clean the pump with a lint-free cloth lightly dumped with warm water and a standard disinfectant/detergent solution, before connecting the pump to a new patient, and periodica lly. Disinfectants which are known to be corrosive to metals must not be used. If the pump will be stored for an extended period of time it should be cleaned and the battery fully charged. Store it in a clean and dry location. During storage, once every 3 months perform functional tests and recharge the internal batteries. Before cleaning, always disconnect the pump from AC main power. Do not steam autoclave, ethylene oxide sterilize or immerse the pump in any liquid. Before using the pump, after long time without use, the battery shall be submitted to a charging-discharging inspection to avoid operation with a battery that is not getting charge and will not work under AC power-off situation. If the battery is not getting charge, it needs to be replaced. Contact Digicare for service. 7. Packing list 1 DigiPump SR7 1 clamp Holder 2 Allen screws for clamp holder 1 Allen tool for attaching clamp holder 1 Power Cable 1 Operator s Manual 17
8.WARRANTY TERMS & CONDITIONS DIGICARE BIOMEDICAL TECHNOLOGY, INC. covers all of their infusion pumps with a 1 year warranty: Infusion Pump DigiPump SR7: 1 year parts and labor Accessories: 90 days on accessories only DIGICARE BIOMEDICAL TECHNOLOGY, INC. will provide the necessary parts and labor to maintain the monitor (s) listed on the Warranty Certificate in a usable condition during the covered period. DIGICARE BIOMEDICAL TECHNOLOGY, INC. will, at its option, repair or replace any product which proves to be defective during the warranty period, if returned to the factory with prior authorization, transportation prepaid. Not covered by this agreement are repairs necessitated by any of the following conditions: 1 - Inadequate power or power failure. 2 - Neglect, abuse or misuse of equipment. 3 - Servicing of equipment by person s other than DIGICARE INC. 4 - Any unit opened or tampered with, without prior authorization. When returning an infusion pump for warranty repair, you must first contact DIGICARE BIOMEDICAL TECHNOLOGY, INC. to receive a Returned Goods Authorization Number (RGA #) that is to be clearly marked on top of the shipping carton. Please make sure that your company name, shipping address, area code and telephone number and person to contact is located in and/or on the box. ANY UNIT THAT IS RETURNED TO THE FACTORY WITHOUT AN RGA# WILL BE REFUSED. Model # Serial # Dealer Name: Date Equip. Purch.: / / Expiration Date: / / DIGICARE BIOMEDICAL TECHNOLOGY INC. 107 Commerce Road Boynton Beach, FL 33426, USA Phone: 561-689-0408 Fax: 561-689-0021 Email:sales@digicarebiomedical.com www.digicarebiomedical.com 18