Zyno Medical Z-800 Скачать руководство пользователя страница 6 | Manualshive

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Zyno Medical Z-800 Скачать руководство пользователя страница 6

Z-800 Instructions for Use.

6/69

P/N 800-600-01-08 Rev 08/10

INTRODUCTION

SYMBOLS

Canadian and U.S. Certification Mark: Products bearing this
mark have been tested and certified in accordance with
applicable U.S. and Canadian electrical safety and performance
standards (CSA C22.2 No. 601.1, UL 2601-1 and IEC 60601-2-
24).

Electrical Shock Protection Rating: Type BF.

IPX1

Protection against fluid ingress: Drip Proof.

Attention: Refer to accompanying documentation.

Rx Only

Federal (U.S.A) law restricts this device to sale by or on the
order of a physician.

Ground Pole. Potential Equalization Conductor (PEC). Note: If
the integrity of the PEC or Hospital Earth System is in question,
operate the instrument using internal battery power.

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Содержание Z-800

Страница 1: ...uctions for Use 1 69 P N 800 600 01 08 Rev 08 10 Z 800 Infusion Pump INSTRUCTIONS FOR USE Revised 08 2010 Zyno Medical LLC 9 Tech Circle Natick MA 01760 1 508 650 2008 Fax 1 508 650 2006 Web www zynom...

Страница 2: ...n Zyno Medical sets with this device Zyno s warranty for its device will be null and void and Zyno will assume no responsibility for any incidents that may occur if the device is not utilized strictly...

Страница 3: ...TPN Mode Infusion 29 Intermittent Mode 31 Blood Mode 34 Prime IV Set Using PRIME Key 36 Powering Off 39 Changing the Primary Solution Container 40 Changing Reloading an IV Set During Infusion 41 Proto...

Страница 4: ...ds and drugs blood and blood products This training should emphasize patient safety and prevention of error This document provides directions for use of the Z 800 infusion pump To ensure safe usage pl...

Страница 5: ...sions Secondary infusions may be delivered at a specified secondary delivery rate and secondary volume to be infused VTBI independent of the primary infusion parameters When secondary VTBI is greater...

Страница 6: ...andards CSA C22 2 No 601 1 UL 2601 1 and IEC 60601 2 24 Electrical Shock Protection Rating Type BF IPX1 Protection against fluid ingress Drip Proof Attention Refer to accompanying documentation Rx Onl...

Страница 7: ...rify the proper function of the display audible and visual alarms WARNING Verify there are no kinks in the tubing when loading into the pump WARNING Always read and follow the instructions that accomp...

Страница 8: ...cies electrosurgical cauterizing equipment portable radios cellular telephones etc may cause false alarm conditions If this happens reposition the device away from the source of interference or use an...

Страница 9: ...Z 800 Instructions for Use 9 69 P N 800 600 01 08 Rev 08 10 DEVICE DESCRIPTION Pump Front View Door Closed...

Страница 10: ...Z 800 Instructions for Use 10 69 P N 800 600 01 08 Rev 08 10 GETTING STARTED DEVICE DESCRIPTION Continued Pump Front View Door Open...

Страница 11: ...Z 800 Instructions for Use 11 69 P N 800 600 01 08 Rev 08 10 GETTING STARTED DEVICE DESCRIPTION Continued Pump Back View...

Страница 12: ...s freely 4 Check for any loose parts NOTE If any of the following conditions are observed the Z 800 pump must be removed from use and inspected by qualified personnel Look for any signs of physical da...

Страница 13: ...ystem power on self test A New Infusion prompt screen will be displayed prompting user to choose either resume a previously interrupted infusion or start with a new infusion 6 If the user elects to re...

Страница 14: ...ical procedure and hang the container approximately 20 inches above the Pump 2 Fill the drip chamber to 1 3 full by squeezing it 3 Open the roller clamp slowly to prime tubing and clear air from the l...

Страница 15: ...TING STARTED LOADING PRIMARY ADMINISTRATION SET Continued LOADING IV SET INTO Z 800 PUMP WARNING Some Z 800 IV sets configurations do NOT have set based free flow protection feature Make sure to close...

Страница 16: ...en User may choose to program the continuous infusion either in RATE VTBI or TIME VTBI The primary infusion programming screen contains the following display areas 1 Status Bar The Status Bar displays...

Страница 17: ...e times to increase the 10 s digit of Pri VTBI to 50 Start Primary Infusion Verify displayed infusion parameter entries Primary Rate Primary VTBI If a clamp is engaged remove the clamp Press RUN STOP...

Страница 18: ...END message This alert will repeat every 5 seconds until the infusion is complete At completion of the infusion an audio prompt sounds Along with the audio prompt the screen will display INFUSION COMP...

Страница 19: ...dary set and prime the set Close the set roller clamp 6 Attach a secondary set to the upper injection site on the primary set 7 Ensure no air bubbles are present in the line 8 Hang the secondary fluid...

Страница 20: ...infusion programming screen contains the following display areas 1 Status Bar The Status Bar displays current operating mode current pump state and volume infused CONT Continuous Mode Operation SET Se...

Страница 21: ...c VTBI to 100 3 Press 10 s Up data entry key five times to increase the 10th digit of Sec VTBI to 50 Change Secondary Flow Rate Use Up Down Arrow keys to highlight Sec RATE Use Data Entry keys to modi...

Страница 22: ...ary infusion execution display contains the following contents Status Bar The Status Bar displays current operating mode current pump state and volume infused CONT Continuous Mode Operation RUN Pump R...

Страница 23: ...STOP key during infusion The infusion will be paused The PAUSE screen will be displayed From PAUSE state press RUN STOP key to resume infusion Changing Rate or VTBI During a Secondary Infusion From th...

Страница 24: ...usion The user may choose the infusion programming parameter option in the pump configuration screen 1 Press the CONFIG soft key to access pump configuration menu from Infusion Programming screens 2 I...

Страница 25: ...amming pump state VINF Volume Infused for the current infusion 2 Infusion Parameters Primary Infusion Time and Primary Volume To Be Infused Pri TIME Primary Infusion Time Pri VTBI Primary VTBI 3 Soft...

Страница 26: ...he KVO flow rate An audio warning tune will sound every 5 seconds until user acknowledgement The Pump will continue infusing fluid into patient with a Keep Vein Open rate of 5ml h The KVO rate of 5ml...

Страница 27: ...Mode Infusion User may choose the 10 STEP infusion mode from CONFIGURATION screen after entering a new infusion 1 Turn on the pump and select NEW INFUSION 2 Use Up Down Arrow keys to highlight 10 STE...

Страница 28: ...on options Up Down Arrows Select parameter items and navigate between current step and previous next step parameter programming Navigate to Previous Next Step Use Up Down Arrow keys to select current...

Страница 29: ...Mode Infusion User may choose the TPN auto ramp infusion mode from CONFIGURATION screen after entering a new infusion 4 Turn on the pump and select NEW INFUSION 5 Use Up Down Arrow keys to highlight 4...

Страница 30: ...ume To Be Infused 3 Soft Keys Allow user to access pump configuration and TPN ramp programming screen CONFIG Access pump configuration RAMP Access TPN Ramp Up and Ramp Down Time parameter programming...

Страница 31: ...1 Turn on the pump and select NEW INFUSION 2 Use Up Down Arrow keys to highlight 5 INTERMITTENT and press the Select soft key 3 The pump will confirm that current application is INTERMITTENT and displ...

Страница 32: ...lume To Be Infused Cycle Time Time for each cycle Hour Minute format Cycle time should be programmed between 30 minutes and 24 hours If programmed Cycle Time is outside the range pump alarms Invalid P...

Страница 33: ...Time Time for each period run Hour Minute format Period time has to be programmed between 10 minutes and 23 hours If programmed Period Time is outside the range pump alarms Invalid Parameters 10 Soft...

Страница 34: ...he BLOOD INFUSION Mode from CONFIGURATION screen after entering a new infusion 1 Turn on the pump and select NEW INFUSION 2 Use Up Down Arrow keys to highlight 6 BLOOD INFUSION and press the Select so...

Страница 35: ...olume infused BLD INTERMITTENT mode operation PRG Pump programming state VINF Volume Infused for the current infusion 5 Infusion Parameters INTERMITTENT Period VTBI and Period TIME of the infusion RAT...

Страница 36: ...patient Press PRIME or PURGE Confirm that the patient is not connected to the administration set Press and hold the key to prime 2 During the prime the pump will run at the fixed prime flow rate of 60...

Страница 37: ...RE pressing the RUN STOP key 3 During KEYPAD LOCKOUT user may Press RUN STOP key to stop and restart infusion Press PRIME key to prime the IV set Press ON OFF key while the infusion is stopped to powe...

Страница 38: ...INF parameter 2 Press CLR key an audio prompt tune will sound and a Clear VINF message screen will be displayed Press OK soft key to confirm the action Press QUIT soft key to abort the action 3 Upon u...

Страница 39: ...OWERING OFF Stop the Z 800 pump by pressing the RUN STOP key during an infusion Press and hold down the ON OFF key for 2 seconds The pump will be put on standby state NOTE Pump cannot be powered off d...

Страница 40: ...mp 3 Remove empty solution container 4 Spike new container 5 Enter primary infusion programming screen Highlight Pri VTBI parameter Use data entry keys to enter desired VTBI 6 Open roller clamp 7 Pres...

Страница 41: ...nect administration set from the patient Open pump door Remove administration set from the pump Prime and load a new administration set as described in Prepare Infusion section Close pump door Open ro...

Страница 42: ...ump and select NEW INFUSION 2 Use Up Down Arrow keys to highlight 7 PROTOCOLS and press the Select soft key 3 The pump will display the protocol names saved on the pump There are up to 3 protocols can...

Страница 43: ...VTBI 250ml 2 From the 10 STEP Programming screen press CONFIG soft key to access CONFIG screen Select 8 BIOMED OPT 3 Inside BIOMED OPT sub menu select 8 6 SAVE AS PROTOCOL 4 Select one of the 3 protoc...

Страница 44: ...lified personnel Alarm An audio and visual signal indicates that a potentially unsafe condition is detected Immediate action is required Under an alarm condition the Z 800 pump is in STOP state The au...

Страница 45: ...ume infusion Occlusion Increased back pressure sensed while infusing Infusion stopped 1 Resolve the cause of the occlusion 2 The infusion will resume when pressure reduced to below the alarm threshold...

Страница 46: ...rrent infusion is paused and there is no user input for more than 5 minutes The audio and visual warning message will appear every 5 seconds until infusion completion Press RUN STOP key Z 800 Pump wil...

Страница 47: ...TROUBLESHOOTING ERRORS Error Meaning Response System Error System has detected an error on the pump Infusion stops Press RUN STOP key to silence alarm and to stop using the affected pump The pump mus...

Страница 48: ...01 1 Medical Electrical Equipment Safety IEC 60601 2 24 Infusion pumps and controllers IEC 60601 1 4 Programmable Electrical Medical System UL 2601 1 and CAN CSA C22 2 No 601 1 Power Requirements 110...

Страница 49: ...to 110kPa Operating Conditions The system may not meet all performance specifications if operated outside of the following conditions Temperature 10 C to 40 C 59 F to 113 F Humidity 30 to 75 R H at 40...

Страница 50: ...tween 4 psi and 30 psi 1 From the configuration menu Select 8 BIOMED OPT 2 In the BIOMED OPTION menu Select 8 1 PRESSURE 3 In the Pressure sub menu use Up Down Arrow to adjust the occlusion alarm pres...

Страница 51: ...icro liters to 280 micro liters The Z 800 s Air In Line Detector alarm threshold can be adjusted by the user 1 From the configuration menu Select 8 BIOMED OPT 2 In the BIOMED OPTION menu Select 8 2 AI...

Страница 52: ...onfiguration menu When enabled the drip sensor will detect the absence of drips in the drip chamber continue to infuse 8mL then alarm and stop the pump 1 From the configuration menu Select 8 BIOMED OP...

Страница 53: ...ng error or prompt Audio alarm volume may be adjusted by the user 1 From the configuration menu Select 9 FACTORY SET 2 In the FACTORY SETTING menu Select 9 3 ALARM VOLUME 3 In the ALARM VOLUME sub men...

Страница 54: ...n be adjusted by the user 1 From the configuration menu Select 9 FACTORY SET 2 In the FACTORY SETTING menu Select 9 1 BRIGHTNESS 3 In the BRIGHTNESS sub menu use Up Down Arrow to adjust LCD brightness...

Страница 55: ...v 08 10 MAINTENANCE STORAGE Store the pump away from excessive heat cold or humidity Keep the pump plugged into an AC outlet during storage to ensure a fully charged battery when needed AC indicator l...

Страница 56: ...expectancy of the battery is dependent on the amount of use the depth of discharge and the state of the charge that is maintained Generally the battery will have the longest life recommended replacem...

Страница 57: ...atteries wear out in that the chemicals and materials used to construct the cell break down It is estimated that there will be a 30 capacity decrease of battery capacity over a 200 full discharge char...

Страница 58: ...ttery to original performance by repeating one or two cycles of fully charging and fully discharging Some temporary reduction in capacity might become apparent if the battery is repeatedly discharged...

Страница 59: ...dine Quaternaries 1 512 WEX CIDE 1 Keep the instrument upright and do not allow any part of the instrument to become saturated with or submersed in fluid during the cleaning operation 2 Use soft cloth...

Страница 60: ...nd must be performed by the user REGULAR INSPECTIONS PROCEDURE FREQUENCY INSPECTION FOR DAMAGE Enclosure Each usage Power Cord Each usage CLEANING As Required START UP SEQUENCE Each usage NOTE If the...

Страница 61: ...culty experienced Z 800 Pump serial number Instrument settings and solution s used Description model and lot number s of the administration sets in use Message displayed at the time of difficulty If i...

Страница 62: ...tial damages in connection with the purchase or use of any Zyno Medical product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or hold...

Страница 63: ...ss the RUN STOP key again to acknowledge the alarm condition Z 800 Pump will be in PAUSE state PAUSE message will appear on the display screen 6 Clear the Air in Line condition Press RUN STOP key agai...

Страница 64: ...ey again to resume infusion Time Delay to Occlusion The maximum time for activation of the downstream occlusion alarm at the minimum flow rate of 1ml hr is around 5 minutes at the minimum occlusion th...

Страница 65: ...time when the Low Battery Warning is presented 6 Verify the following Pump continues to operate during Low Battery warning The Battery indicator turned to red The warning audio tune and a visual messa...

Страница 66: ...are preserved 14 If any one of the following is true contact a qualified service personal to replace the battery Time interval between the Low Battery Warning and Battery Empty Alarm is less then 15 m...

Страница 67: ...et with 1 back check valve and 1 Needle less Access Port on the proximal side universal spike drip chamber 20 drops ml roller clamp male luer lock non DEHP tubing Latex free Approximate priming volume...

Страница 68: ...Filter Sets PART ADMINISTRATION SET DESCRIPTION A2 80071 DF 105 Administration set with 1 Needle less Access Port on the distal side universal spike drip chamber 20 drops ml roller clamp male luer lo...

Страница 69: ...81071 D 104 Administration set with 1 Needle less Access Port on the distal side 2 spikes drip chamber with 180 micron blood filter roller clamp male luer lock non DEHP tubing Latex free Approximate p...

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