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MAINTENANCE

Z-800F Instructions for Use.

P/N 800F-IFU-2602, Rev. O

MAINTENANCE

SPECIFICATIONS

Pumping Mechanism:

Linear Peristaltic

Flow Rate:

1 - 1200 ml/h in 1 ml increments

Priming Rate:

600 ml/h

Volume to Be Infused:

1 - 9,999 ml in 1 ml increments

Accuracy*:

± 5 %

Time Memory is maintained:

Permanent for previous infusion parameters.

Air-in-Line Detector:

Ultrasonic, 14-level configurable

Occlusion Detector:

Pressure sensor. 14-level configurable

Electrical Standard:

Class I, Type BF

Electrical Safety

Complies with: EN 60601-2-24:1998; EN 60601-

1:2006/AC:2010; EN 60601-1-2:2007/AC:2010; EN

60601-1-6:2010; EN 60601-1-8:2007; EN 60601-1-

11:2010, and EN 62366:2008.

Power Requirements:

100 – 240 VAC, 50-60 Hz

Power Consumption:

25 VA (at maximum flow rate)

Internal Battery:

Rechargeable Nickel-Metal-Hydride

9.6V; 4.5 Amp-hr

(Replaceable by qualified service personnel only)

Battery Life at 125 ml/h:

8 hours

Battery Charging:

Automatic when pump plugged into an AC power source

Pump Housing:

Cast Aluminum & Sheet Metal

Weight:

3.2 kilograms, 7.0 lbs

Dimensions:

8.6”H x 5.7”W x 5.3”D

Standards:

Manufactured in a facility certified with ISO 13485: 2003

*The device is calibrated within flow rate accuracy specification under the following conditions:



Test fluid is distilled water at room temperature (21+/-1



C) at ambient air pressure;



Head height is set according to instructions in the IFU;



Test set is Zyno proprietary set at specifications;



Programmed volume during test is no less than 10 mL.

Содержание Z-800F

Страница 1: ...Z 800F Instructions for Use 1 P N 800F IFU 2602 Rev O Z 800F Infusion Pump INSTRUCTIONS FOR USE Zyno Medical LLC 177 Pine Street Natick MA 01760 1 508 650 2008 Fax 1 508 650 2006 Web www zynomed com...

Страница 2: ...e 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 in accordance with its product lab...

Страница 3: ...DE 18 TIME VTBI PROGRAMMING 26 INFUSION COMPLETE 28 TPN MODE INFUSION 29 10 STEP MODE INFUSION 31 INTERMITTENT MODE INFUSION 34 BLOOD INFUSION 37 MANAGING INFUSION 39 PRIME THE ADMINISTRATION SET USIN...

Страница 4: ...ATIONS 53 CONFIGURABLE SETTINGS 55 STORAGE AND TRANSPORTATION 71 BATTERY CARE AND MAINTENANCE 72 CLEANING 75 INSPECTION REQUIREMENTS 76 SERVICE INFORMATION 78 WARRANTY 79 APPENDIX 80 ALARM TESTING PRO...

Страница 5: ...s 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 800F Infusion Pump To ensure safe usage pl...

Страница 6: ...ovides 14 levels of adjustable downstream occlusion alarm thresholds between 4 psi and 30 psi Secondary Infusions Secondary infusions may be delivered at a specified secondary delivery rate and second...

Страница 7: ...602 Rev O SYMBOLS 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 dev...

Страница 8: ...re are no kinks in the tubing when loading into the pump WARNING Always read and follow the instructions that accompany the fluid container and IV administration sets used Carefully follow the instruc...

Страница 9: ...small or large diameters or unusually stiff materials CAUTION Please read the entire contents of this manual before using the Z 800F Infusion Pump CAUTION USA Federal and Canadian laws restrict this...

Страница 10: ...AUTION Always verify displayed infusion parameters Primary Rate Primary VTBI Secondary Rate Secondary VTBI with the prescription before starting infusion CAUTION Grounding reliability can only be achi...

Страница 11: ...GETTING STARTED Z 800F Instructions for Use 11 P N 800F IFU 2602 Rev O DEVICE DESCRIPTION Pump Front View Door Closed...

Страница 12: ...GETTING STARTED 12 Z 800F Instructions for Use P N 800F IFU 2602 Rev O DEVICE DESCRIPTION Continued Pump Front View Door Open...

Страница 13: ...GETTING STARTED Z 800F Instructions for Use 13 P N 800F IFU 2602 Rev O DEVICE DESCRIPTION Continued Pump Back View...

Страница 14: ...reely 4 Check for any loose parts NOTE If any of the following conditions are observed the Z 800F Infusion Pump must be removed from use and inspected by qualified personnel Look for any signs of phys...

Страница 15: ...user to choose either resume a previously interrupted infusion or start with a new infusion 6 If the user elects to resume the previously interrupted infusion the pump will enter into the Programming...

Страница 16: ...he Drip Chamber to 1 3 full by squeezing it 4 Open the Roller Clamp slowly to prime tubing Invert and tap the back Check Valve and any luer lock sites to clear the air from the IV Administration Set 5...

Страница 17: ...RATION SET Cont 12 Open the IV set roller clamp and confirm that there is NO FLOW in the IV set drip chamber Connect the administration set to the patient s injection site LOADING IV SET INTO Z 800F P...

Страница 18: ...TE Primary Flow Rate Pri VTBI Primary VTBI 3 Keys Allows user to access pump configuration and secondary infusion programming screen CONFIG Access configurable settings SEC Access the secondary infusi...

Страница 19: ...y five times to increase the 10 digit of Pri VTBI to 50 Start Primary Infusion Verify the displayed infusion parameter entries Primary Rate Primary VTBI If a clamp is engaged remove the clamp Press RU...

Страница 20: ...ice Along with the audio prompt the screen will display INFUSION NEAR END message This alert will repeat every 5 seconds until the infusion is complete At completion of the infusion an audio prompt so...

Страница 21: ...e drip chamber to 1 3 full 5 Open a secondary 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 that no air bubbles are...

Страница 22: ...Programming Screen Similar to the primary infusion programming screen the secondary infusion programming screen contains the following display areas 1 Status Bar The Status Bar displays current opera...

Страница 23: ...e 100 digit of Sec VTBI to 100 3 Press 10 Up data entry key five times to increase the 10 digit of Sec VTBI to 50 Change Secondary Flow Rate Use Up Down Arrow keys to highlight Sec RATE Use Data Entry...

Страница 24: ...once per second The secondary infusion execution display contains the following contents Status Bar The Status Bar displays current operating mode current pump state and volume infused SEC Secondary...

Страница 25: ...P key during infusion The infusion will be paused The PAUSE screen will be displayed From PAUSE state press the RUN STOP key to resume infusion Changing Rate or VTBI During a Secondary Infusion From t...

Страница 26: ...Mode selection screen 1 Press Home key to access the main page If a confirmation page showing Current infusion parameters will be lost Want to continue is displayed select YES to acknowledge Note Any...

Страница 27: ...ration 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 Keys Allows user...

Страница 28: ...ry 5 seconds until the user presses the RUN STOP key If optional secondary alarm light is connected to the pump this alarm light will turn solid blue or red during KVO mode until user presses the RUN...

Страница 29: ...age If a confirmation page showing Current infusion parameters will be lost Want to continue is displayed select YES to acknowledge Note Any unsaved parameters will be lost upon confirmation 2 Select...

Страница 30: ...Infused 3 Keys Allow user to access pump configuration and TPN ramp programming screen CONFIG Accesses pump configuration RAMP Accesses TPN Ramp Up and Ramp Down Time parameter programming Up Down Ar...

Страница 31: ...the main page If a confirmation page showing Current infusion parameters will be lost Want to continue is displayed select YES to acknowledge Note Any unsaved parameters will be lost upon confirmation...

Страница 32: ...p 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 step paramet...

Страница 33: ...n 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 step parameters a...

Страница 34: ...t YES to acknowledge Note Any unsaved parameters will be lost upon confirmation 2 Select PROGRAM to access Infusion Mode menu 3 In pump Infusion Mode menu use the Up Down Arrow keys to highlight 5 INT...

Страница 35: ...e This displays the time for each cycle in Hour Minute format Cycle time should be programmed between 30 minutes and 24 hours If the programmed Cycle Time is outside the range pump alarms Invalid Para...

Страница 36: ...time for each period run in 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 3 Keys Al...

Страница 37: ...confirmation page showing Current infusion parameters will be lost Want to continue is displayed select YES to acknowledge Note Any unsaved parameters will be lost upon confirmation 2 Select PROGRAM t...

Страница 38: ...mode current pump state and volume infused BLD BLOOD mode operation VINF Volume Infused for the current infusion 2 Infusion Parameters BLOOD flow rate and Volume to Be Infused RATE Blood flow rate VT...

Страница 39: ...then press and hold soft Prime key as indicated below 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 fi...

Страница 40: ...a PANEL LOCKED message will be displayed for 3 seconds 2 During KEYPAD LOCKOUT the user may only press and hold ON OFF key for emergency shut off 3 Any other key press will result a message display of...

Страница 41: ...or secondary infusion during infusion 3 Press the PROG key to return to programming page press and hold CLR key an audio prompt tone will sound and a confirmation screen will be displayed Press the Y...

Страница 42: ...42 Z 800F Instructions for Use P N 800F IFU 2602 Rev O POWERING OFF Stop the Z 800FInfusion Pump by pressing the RUN STOP key during an infusion Press and hold down the ON OFF key for 2 seconds The p...

Страница 43: ...infusion 2 Close the Roller Clamp 3 Remove the empty solution container 4 Spike the new container 5 Go to the primary infusion programming screen Highlight Pri VTBI parameter Use the data entry keys t...

Страница 44: ...5 Release the IV Administration Set from the Free Flow Clamp located at the bottom portion of the pump 6 Push the metal button of the Anti Free Flow Module slide the Anti Free Flow Clamp out and relea...

Страница 45: ...parameter programming screen press Home key to access home page 2 The home page should be displayed Highlight PROTOCOL using Up Down arrows and press SELECT 3 The pump will display the protocol names...

Страница 46: ...s CONFIG screen Select 3 SAVE PROTOCOLS 3 Select one of the 8 protocols to be used to store the infusion parameters Enter the name to be used for the protocol Use the or key to scroll through letters...

Страница 47: ...d 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 800F Infusion Pump is in STOP state T...

Страница 48: ...lusion Increased back pressure is sensed while infusing Infusion is stopped Continuously flashes blue or red notification until user acknowledgement 1 Resolve the cause of the occlusion 2 The infusion...

Страница 49: ...r does not detect the presence of the IV set based clamp in pump The infusion is stopped Continuously flashes blue or red notification until user acknowledgement 1 Acknowledge the alarm by pressing RU...

Страница 50: ...ing will be silenced when AC power is detected Pump Unattended The Z 800F Infusion Pump detects the current infusion is paused and there is no user input for more than 5 minutes The audio and visual w...

Страница 51: ...will sound constantly until user acknowledgement Stays solid blue or red notification until user acknowledgement Press the RUN STOP key The Z 800F Pump will be paused Pump will be due for service soo...

Страница 52: ...ight optional Response System Error The system has detected an error in the pump Infusion stops Continuously flashes blue or red notification until user acknowledgement Press RUN STOP key to silence t...

Страница 53: ...0 and EN 62366 2008 Power Requirements 100 240 VAC 50 60 Hz Power Consumption 25 VA at maximum flow rate Internal Battery Rechargeable Nickel Metal Hydride 9 6V 4 5 Amp hr Replaceable by qualified ser...

Страница 54: ...nditions 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 C non condensing Air...

Страница 55: ...ld can be adjusted between 4 psi and 30 psi 1 From the configuration menu Select 1 BIOMED OPT 2 In the BIOMED OPT menu highlight the PRESSURE option by pressing the Up Down Arrow 3 Press or key to adj...

Страница 56: ...2 micro liters to 280 micro liters The Z 800F s Air In Line Detector alarm threshold can be adjusted by the user 1 From the configuration menu Select 1 BIOMED OPT 2 In the BIOMED OPT menu highlight th...

Страница 57: ...e configuration menu Select 1 BIOMED OPT 2 In the BIOMED OPT menu highlight the KVO RATE option by pressing the Up Down Arrow 3 Press or key to adjust the value 4 Press the SAVE key to confirm the set...

Страница 58: ...warning message will appear every 5 seconds until infusion completion 1 From the configuration menu Select 1 BIOMED OPT 2 In the BIOMED OPT menu highlight the NEAR END WARNING option by pressing the...

Страница 59: ...disable this option refer to Customize the BIOMED OPT Menu page in this section When enabled the drip sensor will detect the absence of drips in the drip chamber continue to infuse 8mL then alarm and...

Страница 60: ...nfusion Configuring Secondary Infusion Option The Z 800 pump has the option to hide the Secondary Infusion option so that it is not selectable by the user To hide or unhide this option select the BIOM...

Страница 61: ...n the BIOMED OPT menu highlight the CLAMP SENSOR option by pressing the Up Down Arrow 3 Press or key will bring out the customization authorization screen 4 Enter the password 1111 by pressing and onc...

Страница 62: ...ess level can be adjusted by the user 1 From the configuration menu Select 2 FACTORY SET 2 In the FACTORY SET menu highlight the BRIGHTNESS option by pressing the Up Down Arrow 3 Press the or key to a...

Страница 63: ...t level can be adjusted by the user 1 From the configuration menu Select 2 FACTORY SET 2 In the FACTORY SET menu highlight the CONTRAST option by pressing the Up Down Arrow 3 Press the or key to adjus...

Страница 64: ...g error or prompt Audio alarm volume may be adjusted by the user to Low Mid or High setting 2 From the configuration menu Select 2 FACTORY SET 3 In the FACTORY SET menu highlight the ALARM VOLUME opti...

Страница 65: ...Enter the password 1111 by pressing and once and pressing 11 times Then press SELECT The pump will enter the customization page The sign before an item means that the item will not be displayed in th...

Страница 66: ...tion authorization screen Enter the password 1111 by pressing and once and pressing 11 times Then press SELECT The pump will enter the customization page The sign before an item means that the item wi...

Страница 67: ...ation screen Enter the password 1111 by pressing and once and pressing 11 times Then press OK The pump will enter the customization page The sign before an item means that the item will not be display...

Страница 68: ...uthorization screen Enter the password 1111 by pressing and once and pressing 11 times Then press OK The pump will enter the customization page The sign before an item means that the item will not be...

Страница 69: ...on authorization screen Enter the password 1111 by pressing and once and pressing 11 times Then press OK The pump will enter the customization page The sign before an item means that the item will not...

Страница 70: ...d 1111 by pressing and once and pressing 11 times Then press SELECT The pump will enter the customization page Use the up down arrow keys to move to the LOAD DEFAULT option Use or to remove the sign a...

Страница 71: ...to ensure a fully charged battery when needed The AC indicator light pictured left will be on whenever the Z 800F Infusion Pump is plugged in When transporting the pump please apply sufficient protect...

Страница 72: ...e the depth of discharge and the state of the charge that is maintained Generally the battery will have the longest life if the pump is always plugged in and the battery use is infrequent Frequent use...

Страница 73: ...imated that there will be a 30 capacity decrease of battery capacity over a 200 full discharge charge cycles within 2 years of normal use As the battery ages the battery operating time will decrease P...

Страница 74: ...y 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 less...

Страница 75: ...e 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 da...

Страница 76: ...UP SEQUENCE Each usage NOTE If the instrument does not pass the regular inspection the affected instrument must be removed from use and inspected by qualified service personnel PERIODIC PREVENTIVE MA...

Страница 77: ...d personnel can reset the odometer value Periodic preventive maintenance of the hardware PM s must only be performed by Zyno certified personnel and are essential for assuring the accuracy and safety...

Страница 78: ...lty experienced Z 800F 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 it...

Страница 79: ...al 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 holder...

Страница 80: ...infusion will stop 5 Press the RUN STOP key again to acknowledge the alarm condition The Z 800F Pump will be in PAUSE state The PAUSE message will appear on the display screen 6 Clear the Air in Line...

Страница 81: ...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 82: ...MP The infusion will stop 5 Press the RUN STOP key again to acknowledge the alarm condition The Z 800F Pump will be in PAUSE state The PAUSE message will appear on the display screen 6 Install the IV...

Страница 83: ...ser acknowledgement Infusion stops 8 Allow the Battery Empty Alarm to continue to sound 9 Record the time the pump shut itself off 10 Connect the device to an approved AC power outlet 11 Turn on the d...

Страница 84: ...heck Valve Needleless Injection Site at proximal side Pinch clamp Roller clamp Male Luer Lock Adaptor Luer Lock Tip protector B2 70071 D 105 266cm Long Fluid path is sterile non Pyrogenic non DEHP Lat...

Страница 85: ...k Tip protector B2 70071 DF 105 266cm Long Fluid path is sterile non Pyrogenic non DEHP Latex free Spike tip protector Universal spike Drip chamber Pinch clamp Roller Clamp 0 22 micron IVEX filter Sli...

Страница 86: ...power cord Standard Accessory 6617A Power Cord Removable 12 feet Hospital Grade AC power cord Optional Accessory 6611B Drip Sensor Drip Chamber Based Flow Sensor Optional Accessory 6612B Secondary Re...

Страница 87: ...Z 800F Instructions for Use 87 P N 800F IFU 2602 Rev O This page is intentionally left blank...

Страница 88: ...88 Z 800F Instructions for Use P N 800F IFU 2602 Rev O Zyno Medical LLC 177 Pine Street Natick MA 01760 USA Phone 1 508 650 2008 Fax 1 508 650 2006...

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