Hawk -i1 User Manual
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Hawk -i1 User Manual

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Hawk-i1 INFUSION PUMP
USER MANUAL
Version: V2.0.1
Shenzhen Hawk Medical Instrument Co. Ltd.
Please read the manual before using the product.
Please keep the manual for reference！
057-00088-00
1

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  • Page 1 Hawk-i1 INFUSION PUMP USER MANUAL Version: V2.0.1 Shenzhen Hawk Medical Instrument Co. Ltd. Please read the manual before using the product. Please keep the manual for reference！ 057-00088-00...

  • Page 2: Table Of Contents

    Contents REVISION NOTES: ......................1 1. WARNINGS AND CAUTIONS ..................1 2. INTRODUCTION ......................5 2.1 F EATURES ......................5 2.2 M AJOR SES AND COPE OF PPLICATION ..............6 2.3 T YPE AND PECIFICATION ..................6 2.4 P RODUCT ODEL ....................
  • Page 3 7. PRECAUTIONS FOR PREPARATION AND OPERATION ..........16 7.1 P REPARATION AND INSPECTION BEFORE ............... 16 7.2 O PERATION RECAUTIONS ..................16 8. OPERATION METHOD ..................... 17 8.1 INFUSION OPERATION ..................17 8.2 A LARMS AND OLUTIONS ..................33 8.3 I NFUSION TUBE ETTING ..................
  • Page 4 13.1 S : ..............52 TANDARD CONFIGURATION IN A PACKAGE 14. OPEN-PACKAGE INSPECTION................52 15. AFTER-SALES SERVICE ..................52 16. EMC INFORMATION ....................53 17. LIST OF FACTORY DEFAULT PARAMETERS ............59 APPENDIX 1 ....................... 59 ABLE LASSIFICATION OF ALARMS AND COLOR OF ALARM INDICATOR LIGHT ......

  • Page 5: Revision Notes

    Revision Notes: The copyright of this user manual belongs to Shenzhen Hawk Medical Instrument Co., Ltd. No unit or individual is allowed to copy, revise or translate this user manual without the consent of the company. On the premise of comply with relevant laws and regulations, we’ll revise the manual timely according to the improvement of products or update of laws and regulations.
  • Page 6 Personal casualties may be caused if precautions mentioned in this warning are violated. A) The Infusion Pump uses peristaltic mechanism for medical fluid infusion, but cannot detect leakage caused by disconnection or crack of infusion set. It is required to inspect the infusion status regularly to prevent above problems.
  • Page 7 of Air Bubble alarm, it is convenient for the user to clamp the flow clip and then squeeze the air bubble back into the drip chamber. H) Fix the Infusion Pump well to infusion stand/bar and also ensure the stability of the stand/bar. Be cautious when moving the stand/bar and the Infusion Pump to prevent the Infusion Pump falling off or the stand collision with surrounding objects.
  • Page 8 stop operation immediately and contact the distributor or the manufacturer. Besides, adhesion or leakage of medical liquid may lead to malfunction of the Infusion Pump. Therefore please clean the Infusion Pump and store it properly after each use. B) When use the Infusion Pump the first time after purchasing or after long-time of storage, please connect it to AC power source and charge it for at least 10 hours with power on, (or 3.5 hours with power-off).

  • Page 9: Introduction

    frequent Air Bubble alarms. I) In normal conditions, try to use AC or DC power source to extend battery service life. When use AC power source, making sure it is well connected to ground and please use the power cord that is standard configuration with the Infusion Pump.

  • Page 10: Major Uses And Scope Of Application

    It cannot be carried by patient for mobile use. It can’t be used in mixed gases of flammable anesthetic gas with air, or of oxygen or nitrous oxide with flammable anesthetic. 2.4 Product Model hawk-i1 Model hawk-i1 Features 1.Rate Mode...

  • Page 11: Impacts On Environment And Energy

    2.6 Impacts on Environment and Energy This infusion pump may have certain electromagnetic radiation and interference on other devices. Such interference, if occurred, should be alleviated by adopting certain measures, such as rearranging position of infusion pump or inducing mains supply from different positions. For more information, please see Part 17 –...

  • Page 12: Technical Characteristics And Parameters

    immediate correct operation. It contains mainly photoelectric alarm (light emitting diode ) , audible alarm (loudspeaker and buzzer) and screen display alarm; HMI: to set parameters of infusion through keys, such as infusion volume and speed. It can display all parameters and current working state through color LCD. 4.

  • Page 13: Installation And Adjustment

    Li_Polymer 7.4V 1900mAh; Recharge time: 10h with power on, 3.5h with power off. Internal battery Running time: more than 10h at rate of 25ml/h, environment temperature 25℃ after being fully charged. Charging and discharging cycle: more than 300 cycles DC12 ± 1.2V, 1.5A, CE certified 25VA Power consumption Slow fuse Specification: 250V 2A...

  • Page 14: Appearance Introduction

    6. Appearance Introduction 6.1 Front View (Diagram 1: Front View) 6.2 Operation Panel...
  • Page 15 Description Function Press this key to silence the alarm sound. The visible alarm info can’t be Silence key removed by SILENCE key Switch on / off the infusion pump. 1.Switch on: in ‘power off’ status, keep pressing this key until LCD screen displays, and the indicator light is on .

  • Page 16: Screen Display

    yellow but not flash. * Please refer to Annex I Table 1 for priority of alarm classification. Charging indicator This indicator light on means the battery is recharging. light This indicator light off means the battery is not charging. 1. When selecting the parameters, press the keys to previous or next parameter.

  • Page 17: Rear View

    (1) Except for the first vertical line, the lines from the left to the right are corresponding to 8 levels of occlusion. The red one means the preset occlusion level. (2) Pressure indicating icon shows the pressure in tube. With the changing of pressure in infusion tube, pressure indicating icon will appear green surge wave.

  • Page 18: Label

    Used for upgrading software or transferring infusion history records. Connect with the PC according with the standard of IEC 60950-1-2005 Information technology equipment - Safety - USB Port Part 1: General requirements to output infusion records to PC. Note: This process must be carried out when machine in non-infusion state.
  • Page 19 IPX3 Waterproof level: dripping water by slope angel 60° AC power DC power Dispose in environmental-friendly way Date of manufacture Manufacturer Stop action Turn on/off Silence alarm sound Caution Against Wet Fragile. Handle with care!

  • Page 20: Precautions For Preparation And Operation

    Keep upright during transport 5 layers at most of the same package Transport package humidity 10 ~ 95% Transport package temperature -20°C ~ 45°C 7. Precautions for Preparation and Operation 7.1 Preparation and inspection before Use Whether the Infusion Pump is a new one, or it has been stored for a period of time, or it just has been repaired, please check the following terms before use: (1) The outlook remains good, clean, no crack and no leakage (2) All keys are responsive.

  • Page 21: Operation Method

    (3)The parameters of infusion pump should be set or changed by trained and professional staffs. (4) The Infusion Pump should be placed within 1.2 meters above or below patient’s heart. (5) If the panel is damaged, please replace it in time to protect the infusion pump from being damaged by the leaked liquids.
  • Page 22 dedicated IV set or IV set is installed in the pump already; Attention: 1. If Air bubble sensor test FAIL, system will show “Is the infusion set installed?”, please choose the answer according to the facts, the system will predicate per your choice. 2.
  • Page 24 ⑥Close the pump door & setting the parameters; Press BOLUS key to exhaust air bubble; Press START key to start infusion; Press STOP Key to stop infusion. When using Hawkmed dedicated infusion set (Fig. 4) , please make sure the correct installation of infusion set (as shown in Fig.
  • Page 25 (Fig. 5: Installation diagram of Hawkmed dedicated infusion set) Attention: Please make sure there is no liquid on the external wall of infusion set, and no liquid flowing to ultrasound sensor; otherwise, it may fail to give air bubble alarm when there is air in line. Drop sensor connection: Install the drop sensor as per above figures (Note: The liquid level should be lower than the red line label).
  • Page 26 (Fig. 6: The main menu ) (Fig.7：Infusion mode interface) Select infusion mode by pressing key, press OK key to enter the parameter setting interface of the infusion mode. The following is methods of setting the parameters of modes: （1）Rate Mode...
  • Page 27 (Fig. 8：Rate Mode) (Fig. 9) After entering parameter setting interface of Rate mode, press to choose the parameter to be edited, it will be marked with blue rectangle background. Press OK key, the blue rectangle disappears, then the current editable position will be marked white 9).
  • Page 28 shows on the screen. Note: If the rate is larger than limits, after pressing Start, it will remind " Flow rate is out of range, please reset the parameters". Here please press to return the parameter setting interface to reset the parameters. Return: If want to reselect the infusion mode, press to return main menu...
  • Page 29 Unit, Drug A, Drug V, Weight and VTBI are adjustable, after confirming, press OK to save. Rate will be automatically calculated by system according to Dose, Dose Unit, Drug A, Drug V, Weight and VTBI, and shows on the screen. If the rate is larger than limits, after pressing Start, it will remind "...
  • Page 30 Rate are adjustable, after confirming, press OK to save. In this mode, two different parameter groups must be set at the same time, the pump will finish the Volumes in order. Otherwise, the pump cannot start infusing and remind “Incorrect parameter, please reset it”. Fig.
  • Page 31 (Fig. 13 Program Mode) After entering parameter setting interface of Program mode, press to choose parameter to be edited, it will be marked with blue rectangle background. Press OK key, the blue rectangle disappears, then the current editable position will be marked white Fig.
  • Page 32 (Fig. 14 TPN Mode) After entering parameter setting interface of TPN mode, press to choose parameter item to be edited, it will be marked with blue rectangle background. Press OK key, the blue rectangle disappears, then the current editable position will be Fig.
  • Page 33 After setting the drop/ml parameter, verify this value. The drip rate was set at 50 drops/m and the preset value was set at 5 ml. Running the infusion and visually measure the number of drops in the actual drip chamber during infusion. If there is a large difference between the drip/ml parameters and the set drip, the drip/ml parameter should be corrected based on the actual visual measurement value.
  • Page 34 In the main menu, press key then press OK key to select “Drug lib”. Press key to select drug category as per request, then press OK key to enter. Press key to select certain drug name, press OK key to enter Drug library mode. Setting the parameters then press OK key to confirm.
  • Page 35 Volume limit 0-9999.99ml Drip rate 0-400drip/min Drip mode Volume limit 0-9999.99ml Volume limit 0-9999.99ml Time mode Infusion Time 0-99h59min Dose 0.1-2000 Volume limit 0-9999.99ml Weight 0.1-300kg Concentration 0.1-2000 Weight mode mg/kg/h, mg/kg/min, mg/h, mg/min, Dose unit ug/kg/h, ug/kg/min ug/h, ug/min Flow rate 0.1-1200ml/h Intermittent mode...
  • Page 36 Down time 0Hrs 0Min-99Hrs 59Min 8.1.5 Purge Press Bolus key until the air bubble in infusion tube is totally exhausted, and then close the flow clamp tightly. The volume generated by “purge” is not calculated in accumulated volume. Note: “purge” only use when machine is in non-infusion status, and infusion tube is not connected to patients.

  • Page 37: Alarms And Solutions

    8.1.10 Replacement of infusion set and liquid container ★ If you need to replace IV set, please follow steps below: Close the flow clip of IV set. Open the pump door and take out the IV set. As per instructions of 8.1.3, fill the new IV set with medical fluid and install it properly. Restart infusion as required.
  • Page 38 No operation is made after 2min Press any key to eliminate the alarm Operation forgotten when the pump is in ★ Remark: This alarm can be set off, refer alarm non-operation and non-alarm to 8.4.9 of this Manual for details. status after turning it on.
  • Page 39 3. The sensor of infusion pump Please contact the distributor or is faulted manufacturer to repair. AC powder-down AC power cord falls off/is cut off Press SILENCE to eliminate alarm. alarm after turning the device on Insert the AC/AC power cord again. 1.
  • Page 40 Take off the infusion set, then turn off 1. Start the device after and turn on the machine to eliminate the Infusion pipe error installation of hawkmed alarm. alarm dedicated infusion set ★ Note: The infusion pump only has this function when it works with hawkmed dedicated infusion set.
  • Page 41 Press SILENCE key to eliminate alarm sound; detect if the infusion bottle is empty and detect if the drop sensor is correctly installed. Press Clear key and 1.Liquid Volume Empty alarm then Start key to start infusion again. Please ask the manufacturer to inspect and repair if the alarm still cannot be Drip rate alarm eliminated.

  • Page 42: Infusion Tube Setting

    The device will display battery exhausted, stop operation and give alarm sound when battery voltage is lower than 6.65V. 5). Occlusion alarm When infusion set is blocked artificially in operation process, the pressure indicator will increase to the right and the device will display occlusion and give alarm sound after a period of time (depends on flow rate).
  • Page 43 Select “setting” on main menu, press OK key, use arrow keys to select “Calibration” to enter IV set calibration interface. Install the infusion set as per instructions in 8.1.3 and prepare liquid volume/weight measuring device. Press START key, the Infusion Pump shall start infusion at 150ml/h and “Calibrating” will show on the interface.

  • Page 44: System Setting

    8.4 System Setting Select “Settings” in the main menu, press OK key to enter. Press key to select requested parameter, press OK key to make it editable, input required value, then press OK key to save the setting. All the setting parameters can be saved automatically after turn off the device, and storage time is 5 years.
  • Page 45 8 levels occlusion pressure adjustable, pressure range: 10Kpa~ 160Kpa. (If patients are elderly or children, it shall be set at low level.) The occlusion level and corresponding pressure value are shown as follows: (Table 843-1) Occlusion icon Pressure Occlusion icon Pressure range level display...
  • Page 46 will run at Bolus rate until finishing the VTBI, then run at original rate. Press to turn to next page. 8.4.6 Back light Setting There are 10 levels of backlight. Select the progress bar per requirement, then press OK to save it. The fewer bars, the darker backlight 8.4.7Key Sound Setting After entering “Key sound”...
  • Page 47 port (according to actual USB port) b. In 115200 property box, click on the “configuration”. Set the baud rate as 115200, date flow controls as Xon/Xoff. c. After the setting, click call icon , connect the terminal. d. In the super terminal interface, select the “transfer - capture text”. Establish a txt file named after a infusion pump serial number and then click “start”.
  • Page 48 8.4.13 Auto switch off setting Select “never” or “1-99” minutes according to the requirements and press OK key to save the parameters "1-99" minute means that in the non-infusion non-alarm state, Infusion pump automatically shutdown after "1-99" minutes without operation. 8.4.14 Language setting After entering “Language”...
  • Page 49 pressure range of the gear, if it is low, increase the pressure base value, if it is too low, it will increase the pressure base value, If it is too high, it will decrease the pressure base value. Note: It is necessary to observe the patient's physical condition at any time after changing the gear. If the patient is unwell, immediately stop to infusion and change back to the original gear.
  • Page 50 IV Set BOON Near Done Drop/ml 1ml=20 drops Night mode Key lock Never Up pressure Rate: 150ml/h Calibration Dedicated IV set VTBI: 10ml Wireless Drip sensor Note: restore the factory settings, please calibrate the IV set again. 8.4.16.7 Drop/ml setting After entering “D./ml”...

  • Page 51: Operation Precautions

    This option is mainly to display the machine's software version, communication information, battery information, AC information, and air bubble sensor information. 8.5 Operation Precautions After the IV set is continuously used for 6 hours, please change the section of IV set that is against ...
  • Page 52 The IV set is too soft or too thin Replace IV set Select a higher level air bubble filter. Frequent Bubble ★ Note: After changed pressure alarm level, please observe patients’ Small air bubble in the IV set condition continually, if feel uncomfortable, shall stop infusion and return to previous pressure level immediately.

  • Page 53: Safety Invention And Troubleshooting

    10. Safety Invention and Troubleshooting 10.1 Safety Invention and precautions (1) AC power: built-in double fuses. When short circuit or any other malfunction occurs, the fuse shall cut off circuit in advance. (2) DC input: built-in fuse. When short circuit or any other malfunction occurs, the fuse shall cut off circuit in advance.
  • Page 54 (2) Keep pressing BOLUS key until liquid drops from the tip of needle. (3) Open the pump door. (4) Observe and confirm no liquid drips from the needle and no liquid drops into drip chamber. 11.3.2 Check the alarm function of occlusion sensor (once every 2 months) Check if the Occlusion alarm is given within 2-10 seconds.

  • Page 55: Normal Repair Procedures

    because they are not easy to be replaced. Battery replacement steps are listed as follows: (1) Unscrew the screws at the bottom of machine; remove the battery cover. (2) Unplug the battery cable and take out the battery. (3) Install the new battery. Please make sure the battery cable won’t be squeezed by the battery Cover. Then install battery cover.

  • Page 56: Storage Conditions

    3. Relative humidity: 10～85% (no frosting) 4.Atmosphere pressure: 50.0kPa～106.0kPa 12.2 Storage Conditions Storage temperature: -20℃～+45℃(With battery); -20℃～+60℃(Without battery) Relative humidity: 10～85% (no frosting) Atmosphere pressure: 50.0kPa～106.0kPa 13. Package list 13.1 Standard configuration in a package: ① Infusion Pump 1unit ② AC power cord 1set ③...

  • Page 57: Emc Information

    3. Malfunction or damage caused by fire, salt, poisonous gas, earthquake, hurricane, flood, abnormal electric voltage or any other natural disaster. For all the malfunctions and damage due to above reasons, the manufacturer can offer repair but charge for the cost. 16.
  • Page 58 Guidance and Manufacturer’s Declaration The infusion pump is intended for use in the electromagnetic environment specified below. The customer of the user of the Infusion pump should assure that it is used in such an environment. Emission Test Conformance Electromagnetic Environment – Guidance The infusion pump use RF energy only for its Radio frequency emission internal function.
  • Page 59 The floor should be covered with wood, Electrostatic ±8 kV contact concrete or tiles; if it is ±8 kV contact discharge discharge discharge covered by composite ±15 kV air discharge IEC 61000-4-2 ±15 kV air discharge materials, then the relative humidity should be at least 30%.
  • Page 60 Level level Guidance Portable and mobile RF communication device should not be closer to any part of Hawk-s1 infusion pump than the recommended isolation distance while using, including cables. This isolation distance should be calculated with the RF conduct 3 V(effective...
  • Page 61 RF radiation GB/T 17626.3 3 V/m 3 V/m 80 MHz~2.5 GHz 80 MHz~800 MHz 800 MHz~2.5 GHz —the maximum rate output power of transmitter provided by transmitter manufacturer, in W; d—recommended isolation distance, in m The field strength of fixed RF transmitter is determined by the survey of electromagnetic field.
  • Page 62 Recommended Isolation Distance between Portable and Mobile RF Communication Device and the infusion pump The infusion pump is expected to use in the electromagnetic environment where RF radiated disturbance is under control. According to the maximum rated output power of communication device, purchasers or users can prevent electromagnetic interference by maintaining the minimum distance between portable and mobile RF communication device (transmitter) and the infusion pump.

  • Page 63: List Of Factory Default Parameters

    17. List of Factory Default Parameters Parameters Factory defaults Parameters Factory defaults 1ml/h Volume High Purge 600ml/h Backlight Bolus 1,000ml/h Key tone occlusion Medium Pressure Operation Bubble forgotten almost done Infusion pipe Pipe A alarm Drop /ml 1ml=20 drops Night mode Flow rate 150ml./h volume to be Calibration Key lock...
  • Page 64 Infusion completion alarm High as priority Red light /2Hz Almost done alarm Medium as priority Yellow light /0.5Hz AC Power off alarm Low as priority Yellow light long bright Forget operation alarm Low as priority Yellow light long bright Table 2 Alarm Conditions and Alarm Signal delay Name of alarm Alarm Condition Alarm signal delay...
  • Page 65 Table 3 Characteristic Parameter of Alarm Sound Table 4 Occlusion response characteristics Flow rate Occlusion Blockage Occlusion alarm time Dosage (ml/h) Alarm Level Pressure (ml)) (KPa) 0h52min11sec 0.26 Medium 1h9min16sec 0.39 High 1h32min1sec 0.45 0h1min45sec 0.26 Medium 0h2min29sec 0.42 High 0h3min34sec 0.50 BOON infusion set is used in this test.
  • Page 66 Table 5 Starting Curve BOON infusion set is used as test tube. The whole test is under room temperature. 1ml Starting Curve 25ml Starting Curve...
  • Page 67 Table 6 Trumpet Curves 1ml Trumpet Curves 25ml Trumpet Curves...

  • Page 68: Appendix 2 Flow Accuracy Test Method For Infusion Pump

    Appendix 2 Flow Accuracy Test Method for Infusion Pump 1. Test method: gravimetric method 2. Principle Gravimetric method uses electronic balance. Connect calibration system as per diagram 2-1. Put certain volume of fluid into container (Container should add lid. If without lid it should add certain amount of paraffin oil to prevent evaporation).
  • Page 69 measuring the flown-out liquid (the balance reading after infusion finish – balance reading before infusion), input this volume on “actual” text of calibration interface. Then press OK key to save the value and exit. The calibration of infusion set is complete. 5.7 After calibration, set flow rate at 150ml/h, volume limit as 10ml.
  • Page 70 Shenzhen Hawk Medical Instrument Co., Ltd. Address:5/F, Building No.2, Lijincheng Industrial Park, East Gongye Road, Longhua district, Shenzhen, C hina Tel: 0086-755-83151901 Fax: 0086-755-83151906 Email: szhk@hawkmedical.cn www.hawkmedical.cn EU Representative: Wellkang Ltd Address: Suite B, 29Harley Street London W1G 9QR, England, United Kingdom...

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