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Zyno Medical Z-800 Instructions For Use Manual Download Page 35

 

Z-800 Instructions for Use. 

 

35/69 

P/N 800-600-01-08 Rev 08/10

 

 

GETTING STARTED 

BLOOD INFUSION (Continued) 

 
 

Programming Blood Infusion Mode parameters 

 

Blood infusion programming screen contains the following 
display areas: 
4.

 

Status Bar

:  The Status Bar displays current operating 

mode; current pump state; and volume 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. 

 

RATE

:  Blood flow rate. 

 

VTBI

:  Volume To Be Infused. 

6.

 

Soft Keys

:  Allow user to access pump configuration 

programming screen. 

 

CONFIG

:  Access pump configuration.  

 

Up/Down Arrows

: Highlight the selected parameter 

item. 
 

The RATE and VTBI parameters may be programmed by 
using the UP/DOWN Arrow keys and Data Entry keys.

 

 

 

 

 

 

 

Summary of Contents for Z-800

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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