Smiths H-1000 Fluid Warmer Service Manual
Contents
1. Smiths Medical Level 1 and Smiths design mark are trademarks of the Smiths Medical family of companies The symbol indicates the trademark is registered in the U S Patent and Trademark office and certain other countries OMDOAN O O A RAR OODD N DP PO PO PP PP PNP PP PPO Nh S AH Aa a a a CO O1 O1 gt F NS NN O O O O Q Q l l O O1 OQ c N N Cover pictures the H 1025 a combination of the H 1000 Fluid Warmer and two accessory H 2 Pressure Infusion Chambers The products described are covered by one or more of the following U S Patent Nos 4 759 749 4 878 537 4 900 308 5 063 994 5 097 898 and 4 678 460 other patent s pending 2006 Smiths Medical family of companies All rights reserved Operator s Manual Part 4533801 Rev 001 2006 08 About This Manual These instructions contain important information for safe use of the product Read the entire operator s manual including Warnings and Cautions before using the Level 1 H 1000 Fluid Warmer Failure to properly follow warnings cautions and instructions could result in death or serious injury to the patient WARNING Messages that are headed by WARNING indicate information or procedures that if not followed correctly can cause improper results damage to the equipment injury to personnel or patient death Messages that are headed by CAUTION indicate information or procedures that if not f2. If the tube is bent serious patient injury or death could result 2 Slide the top 2 socket up Snap the heat exchanger into the heat exchanger guide Be sure it is fully seated Slide the top heat exchanger socket down over the heat exchanger tube 3 Insert the Filter with Gas Vent into the 3 holder on the front of the cabinet 4 Press the green power switch on the front of the cabinet to turn ON the unit and allow it to reach operating temperature while the disposable set is being primed It takes between 3 and 7 minutes for the water in the H 1000 to reach operating temperature 12 When the H 1000 is plugged in and turned ON and the disposable set is correctly installed a green OPERATING light will illuminate and the water temperature will begin to increase on the display panel If the disposable set is incorrectly installed and the unit is turned ON the yellow CHECK DISPOSABLE light will illuminate and an intermittent alarm will sound Priming Disposable Sets WARNING Set up priming and use require aseptic technique Follow applicable hospital policy and procedures WARNING Remove all air from fluid bags before spiking with D series disposable set WARNING All air must be removed from fluid lines prior to patient connection Failure to do so could result in the introduction of air to the patient WARNING Monitor fluid lines to ensure they are air free Never infuse fluids if there are bubbles
3. USA Canada 1 800 258 5361 International 1 781 878 8011 www smiths medical com 23 NOTE Please write the RGA on the outside of the shipping box Non Warranty Service Units received which have suffered obvious abuse or impact damage and units no longer under Warranty will be promptly inspected and a written estimate of repair costs will be sent or faxed A purchase order will be required from the hospital consistent with the written estimate SERIAL NUMBER LABEL Units returned for warranty service must have serial numbers intact Those with missing or altered serial numbers will be serviced as non warranty repairs PROMPT DISPOSITION Smiths Medical will make every effort for prompt correction or other adjustment with respect to any product which proves to be defective Specifications If any electromagnetic or other interference between devices is found during normal use please notify your local authorized distributor or Smiths Medical for assistance This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide Additional circuit diagrams and information are available upon request This device complies to EN 60601 1 EN 60601 1 2 Mode of operation Type of protection against Continuous electric shock Class Degree of protection Degree of protection against against ingress of water electric shock IPX 1 Type BF Physical Specifications Length
4. to be free of material and workmanship defects for a period of 1 year 12 months from the date of purchase abuse and impact damage excluded Smiths Medical reserves the right to replace any or all components in lieu of repair During the period this warranty is in effect any Level 1 H 1000 H 1025 Fluid Warmer found to be defective and shipped to Smiths Medical shipping costs prepaid will be repaired or replaced This warranty does not cover misuse impact damage or obvious abuse of the device No warranty or affirmation of fact expressed or implied other than stated above is made or authorized by Smiths Medical and Smiths Medical s liability in all events is limited to the purchase price paid for the device NOTE Federal U S A Law requires contaminated Medical Equipment to be cleaned and disinfected before shipment If this is not done your unit will be immediately returned as it is received Be sure that ALL water is drained from the unit before packing and shipping FOR QUESTIONS CONTACT YOUR AUTHORIZED DISTRIBUTOR OR THE SMITHS MEDICAL SERVICE DEPARTMENT at 1 781 878 8011 Be sure that all of the following information is included hospital name address telephone number contact person serial number of the device and the apparent problem For Service contact your Smiths Medical distributor or the Smiths Medical Technical Service Department at USA Canada Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA
5. will void the warranty and transfer the liability for any malfunction to the servicing organization Smiths Medical reserves the right to make changes without further notice to any products herein to improve the reliability function or design 25 Electrical Parts List CAP P 1UF CERM C2 C3 C4 C13 CW20C104 60 02 003 Cl CAP HEX 0 68UF LNFILTR 60 02 011 C5 C20 CAP 1UF 60 02 012 C6 C7 C8 C10 C14 C15 C16 C17 C21 CAP 10UF 25V TANTALUM 60 02 001 C11 CAP 470UF LOW ESR 4 60 02 015 C18 CAP 100UF LOW ESR 10 60 020 014 C9 CAP 220UF 35V ELEC 60 02 004 C12 CAP 100 PF IKV CERMDIS 60 02 002 R68 0 1 RES 0 1 OHM 60 01 086 R1 R5 R6 R13 R15 R24 R60 484 R89 R91 RES 1 0K MF1 8W 1 60 01 049 R59 R88 RES 2K 20 Turn TOP AD 60 01 018 R47 R48 R61 RES 3 0K CF1 4W5 60 01 022 R32 RES 3 83 K MF1 8W1 60 01 079 R90 R96 RES 4 02K MF1 8W1 60 01 091 R43 R50 R57 5 1K CF1 4W5 60 01 082 R45 10K CF1 4W5 60 01 012 R7 R17 RES 11 0K MF1 8W1 60 01 019 R10 R14 R23 R69 R86 RES 11 8K MF1 8W1 RN 60 01 076 R46 RES 13K MF1 8W 1 RN 60 01 081 R25A D R28A D R29A D R33 R38 R39 R49 R55 R58 R63A D R64 R77 R78 R81 RO7A D RES 15K SIP FRI4 153G 60 010 55 R18 R19 R22 R70 R71 R74 R76 R85 R87 R93 RES 15 4K MF1 8W 1 60 01 001 R65 R94 RES 15 8K MF1 8W 1 60 01 027 R66 RES 19 6K MF1 8W 1 RN 60 0
6. ALARM indicate the heat exchanger is NOT properly installed rC 14 ADD WATER This Yellow indicator and pulsing AUDIBLE ALARM indicate additional distilled water must be added to the water reservoir 5 WATER OVER TEMPERATURE This RED indicator and AUDIBLE ALARM indicate an over temperature condition Press and hold this switch to confirm proper operation of the OVER TEMP circuitry NOTE When any one or more of the alarms are activated and the red and or yellow indicators are illuminated and the audible alarm is sounding no water is circulating and no fluid warming is taking place Interlocks Three low voltage interlocks are located in the cabinet They sense the presence of a properly installed heat exchanger and filter with gas vent These interlocks prevent the pump from pumping water when there is no disposable in place to complete the circulation loop If the CHECK DISPOSABLE alarm is activated and the light next to the 2 socket is illuminated press the 42 socket down firmly to engage the interlock switch The H 1000 display panel provides information for safe convenient set up and use of the device Accessories H 1025 Pressure Infusers The H 1000 is equipped with an onboard compressor that is used to operate two Level 1 pressure infusion chambers H 2 s Pressure Infusion chambers are sold separately as an accessory to the H 1000 The H 1000 combined with two pressure infusion chambers is referred to as the H 1025
7. OFF The orange switch on the right powers OFF the unit 3 ALARM TEST This alarm test button confirms proper operation of visual and audible alarm systems Press and hold this button to test alarm systems When the switch is released the WATER OVER TEMPERATURE alarm will continue to sound This is normal operation To clear the alarm condition turn the unit OFF and then back ON ai 4 OVER TEMPERATURE TEST This alarm test button confirms proper operation of the OVER TEMPERATURE circuitry Press and hold this button to test this alarm circuitry When the switch is released the WATER OVER TEMPERATURE alarm will continue to sound This is normal operation To clear this alarm condition turn the unit OFF and then back ON Figure 3 Power and Alarm Panel Figure 4 Display Panel Bs 5 E 3 f x 1 4 Liters H O Display Panel The display panel shown in Figure 4 contains visual information that continuously indicates the status of the H 1000 during operation Five displays provide information for safe convenient use of the device 1 CIRCULATING WATER BATH TEMPERATURE Displays temperature of the circulating water bath in C This is not the temperature of the fluid delivered to the patient 2 SYSTEM OPERATIONAL This GREEN indicator illuminates when the power switch is ON and the heat exchanger has been properly installed 3 CHECK DISPOSABLES This Yellow indicator and pulsing AUDIBLE
8. Pressure Infusers are not required to operate the H 1000 but are a valuable accessory to complete this total fluid management system H 1025 pressure infusers provide controlled convenient pressurization of I V blood and fluid bags for rapid administration of fluids These automated pressure chambers quickly reach and hold a preset pressure of 300 mmHg for high speed fluid delivery not possible with manually pumped pressure cuffs The factory set 300 mmHg pressure is constant and not adjustable At 300 mmHG pressure flow rates may be altered by adjusting the roller clamp on the Level 1 D series disposable I V fluid warming set With the H 1025 infusion chambers pressure can be applied or released with the throw of a switch Empty l V fluid bags can be de pressurized replaced and repressurized in seconds Each pressure infuser contains an expansion bladder to accommodate either a 500 ml bag or a 1000 ml bag And a safety relief valve is also contained in each chamber to help prevent over pressurizing fluid bags If you have purchased a pair of pressure infusion chambers please refer to the following pressure infuser set up instructions for proper installation Packaging for each pair of H 1025 pressure infusers should contain the following items Contents Quantity H 2 Pressure Infuser 2 Y Connector 1 Black Tubing 1 Set up and Use CAUTION This device must be assembled and tested by Smiths Medical technical personnel an authorized
9. distributor of Smiths Medical or a trained biomedical engineer prior to placing the device in service WARNING Level 1 pressure chambers are to be used only as a component of the Level 1 fluid warmer Do not connect to compressed gas bottles O R Air or any other pneumatic pressure source Be sure that the chrome poles on the H 1000 are in the upright position 1 Loosen the two pole mounting thumb screws on the back of one H 2 pressure chamber as seen in Figure 5 Slide the H 2 over the top of the flanking bracket 2 Secure the H 2 in place by tightening the two pole mounting screws 3 Repeat steps 1 and 2 for the second H 2 pressure chamber 4 Remove the orange plug from the red ring connector located on the back of the H 1000 This is done by depressing the red plastic ring and pulling the plug out 5 Press the piece of black pneumatic tubing firmly into the connector on the back of the H 1000 until it bottoms out Press the other end of the tubing into bottom of the Y connector Remove Plug and insert black tubing 6 Press the black tube from one of the H 2s into the Y connector Press the black tube from the gt other H 2 into the Y f i connector Figure 5 Installing Pressure Infusers Once the H 1000 is turned on 300 mmHg pressure can be automatically applied by pushing the toggle switch on the top front of the H 2 chamber all the way over to the or ON position Always make sure tha
10. in the line between the filter chamber and patient connection 1 CLOSE the Y Set clamps 2 Remove one bag spike cap and spike it into an air free fluid bag with a twisting motion 3 Hang the fluid bag from the adjustable I V pole and open the lead clamp to the I V bag 4 Squeeze the drip chamber to the I V bag so it is 1 3 to 1 2 full 5 Remove the male luer cap on the patient line and open the Y set clamps to the I V bag 6 Close the patient line clamp when the disposable set is completely primed The filter with gas vent will self prime 7 Gently tap the filter with gas vent against the cabinet to release all trapped air Priming is complete Make patient connection without entrapping air 8 Adjust flow rate using roller clamp Filter with Gas Vent Replacement in I V Disposable Sets Replace the filter with gas vent every THREE HOURS or when the filter becomes clogged or air is slowly vented Replace with Level 1 product number F 10 or F 30 Refer to disposable packaging for appropriate filter replacement product number 13 WARNING Replacement filter with gas vent must be fully primed before continuing infusion Thoroughly check patient line for air bubbles before opening roller clamp If air bubbles are present disconnect from the patient and re prime before continuing infusion 1 Close all clamps on the D series disposable set and on new filter with gas vent 2 Remove the used filter with gas vent from
11. the fan filter with a screwdriver from the bottom of the unit and clean with warm soapy water Maintenance and Testing Log All maintenance and testing should be done by qualified personnel Every 30 days Change Distilled water Lubricate O Rings o j j bo o LX dq pL d j d T Test alarm switch Every 12 months Replace O rings L T L L L TL TL GeanFanFier L L L j L L l L Test Add Water Alam L L T Lo gp cp j qe x LL emite Ground Continuity L L r F T S S T NR RN ERN E MEN x Performance Test Verify Temperature Calibration E HE a Service ALL SERVICE MUST BE PERFORMED BY SMITHS MEDICAL OR ITS AUTHORIZED AGENTS SERVICE BY OTHERS VOIDS THE WARRANTY AND TRANSFERS LIABILITY FOR MALFUNCTIONS OF THE DEVICE TO THE SERVICING ORGANIZATION Warranty Service Units received for repair which have not been obviously abused or impact damaged and are still under warranty will be promptly repaired and returned at no charge Contact your 22 authorized distributor or the Smiths Medical Service Department before shipping the unit to Smiths Medical for repair The Service Department will issue a Return Goods Authorization Number RGA The Service Department will need the SERIAL NUMBER of your unit and a description of the problem This Level 1 Fluid Warmer is warranted by Smiths Medical ASD Inc Smiths Medical
12. to be sure all clamps are fully open TUBE SET Leaving clamps engaged for extended periods of time when the Disposable Set is not in use such as pre set up will cause the tubing to take a SET in the clamped position TUBE KINK Be sure no tube kinks are present anywhere in the set especially in the Y set when a pressure cuff is employed and the IV Pole is used in a lowered position TRAPPED AIR IN FILTER As noted in the Priming instructions remove the Filter from the holder and tap against the Cabinet to dislodge air bubbles and allow them to vent out CLOGGED FILTER If good quality blood is used this filter should never cause flow restriction In the event of a clogged filter this component may be changed If frequent clogging is encountered discuss the QUALITY of the blood being used with your Blood Bank EXTENSION LINES Use only extension lines with a bore of 130 3 3 mm or larger equipped with large bore fittings such as Level 1 Part No s X 36 or Y 30 STOPCOCK OR Y ADAPTER Any fittings attached to the male luer lock at the end of the Patient Line should have large bores If their bores are smaller than the male luer lock bore they are restrictors NEEDLE or CATHETER If possible use a minimum 18 Gauge needle or 16 French catheter Smaller sizes will reduce flow 16 Testing The H 1000 is equipped with disposable set sensing interlocks To operate the device and perform testing operations a Level 1 no
13. 1 111 R31 R44 RES 43K CFI AW 5 60 01 083 R27 R72 RES 46 4K MF1 8W 1 60 01 031 R95 RES 86 6K MF1 8W 1 60 01 034 R92 RES 105K MF1 8W 1 RN 60 01 064 R41 R42 RES 120 0K CF11 4W 5 60 01 013 R80 RES 200K CF11 4W 596 60 01 084 R53 RES 249K MF1 8W 1 60 01 071 R2 R4 RES 270 OHM CF1 4W 5 60 01 020 R37 RES 453 MF1 8W 1 RN55 60 01 051 R12 RES 487 MF1 8W 1 RN 60 01 085 R20 R26 R34 R75 R83 RES IMEG MF1 8W 1 RN 60 01 073 26 Electrical Parts List R8 R11 R16 R54 RES 8 2MEG CF1 4W5 60 01 021 R52 on sheet 5 RES 1OMEG CF1 2W5 60 01 017 LP324 IC LP324 OPAMP 60 05 008 LP329 IC LP339N OR AN QUAD COMP 60 05 001 U3 U4 IC OPTOCOUPLER MOC3063 60 05 010 F1 F2 SLOW BLOW FUSE 1 5A 60 23 028 F3 F4 FUSE SLOW BLOW PIGTAI 60 23 017 CR10 LED YELLOW SUPER BRIGHT 60 10 012 CR8 CR10 CR11 CR14 CR15 CR16 CR17 CR18 CR19 C20 CR21 CR22 CR23 LED RED SUPER BRIGHT 60 10 017 CR1 CR2 CR12 LED GRN SUPER BRIGHT 60 10 018 VRI IC 10V REF MC1404U10 60 05 018 VR3 SWITCHING REGULATOR 60 05 019 U14A U14B U14C IC ULN2004A U14D U14E U14F U14G MOTOROLA 60 05 009 CR9 DIODE 1N4001 60 03 005 U16 LCD JEWELL MVOLT MTR 60 10 004 J6 J11 HEADER 4 PIN STRGT AMP 60 46 011 J4 HEADER POS LOCKING AMP 60 46 063 J5 J9 J12 J13 HEADER 3 PIN STRGT AMP 60 46 010 J7 HEADER 5 PIN STRGT AMP 60 46 012 J8 HEADER 2 PIN STRGT AMP 60 46 009 J10 HEADER 6 PIN STR
14. 81cm A short procedure to verify the displayed circulating water bath temperature is as follows 1 Install TCW in machine in normal heat exchanger position Socket s 1 amp 2 and install a test filter assembly at holder 3 2 Turn the machine on and allow to warm up for 20 minutes Insert thermometer probe fully into well and allow display to stabilize Compare temperatures 3 The H 1000 display will be within 0 3 C of the thermometer display on a correctly calibrated unit Examples a If the thermometer reads 41 4 C and the H 1000 is within the range of 41 1 C 41 7 C performance is acceptable b If the thermometer reads 42 0 C and the H 1000 is within the range of 41 7 C 42 3 C performance is acceptable NOTE If the system does not conform to within these specifications it should be returned to Smiths Medical or an authorized distributor of Smiths Medical for service 3 D SERIES CALIBRATION THERMOMETER TempCheck Available from Smiths Medical the TempCheck device may also be used to test performance and confirm proper calibration of the water bath temperature The D series TempCheck device accurately verifies the temperature of the H 1000 circulating water bath It plugs into the auxiliary outlet on the bottom of the H 1000 and does not require a separate NIST traceable digital thermometer for operation Earth leakage The H 1000 must be tested according to IEC 601 1 clause 19 Earth leakage cu
15. GT AMP 60 46 038 SW1 TILT SW NC 60 40 041 SW2 USWITCH B2 500571 OTTO 60 40 042 Ul U2 IC TRIAC Q6025L6DGE 60 050 13 RECTIFIER CR5 CR6 DB101 60 05 012 DUAL FLIP FLOP U12A U12B MC14013BON 60 05 021 RELAY OMRON Kl G6C2117P U 60 20 011 27 International Symbols PIR OB b r CIRCULATING WATER BATH TEMPERATURE Displays temperature of the circulating water bath in C This is not the temperature of the fluid delivered to the patient SYSTEM OPERATIONAL This GREEN indicator illuminates when the power switch is ON and the heat exchanger has been properly installed CHECK DISPOSABLES This Yellow indicator and pulsing AUDIBLE ALARM indicate the heat exchanger is NOT properly installed There is also a RED indicator next to the top socket that illuminates if the 2 socket is not seated properly ADD WATER This Yellow indicator and pulsing AUDIBLE ALARM indicate additional distilled water must be added to the water reservoir WATER OVER TEMPERATURE This RED indicator and AUDIBLE ALARM indicate an over temperature condition Press and hold this switch to confirm proper operation of the OVER TEMP circuitry ALARM TEST Press and hold this button to confirm proper operation of alarm systems When the switch is released the OVER TEMP will continue to sound This is normal operation To clear the alarm condition turn the unit off and then back on OFF Only for a part of EQUIPMENT Mains are still connected ON On
16. Smiths OPERATOR S AND SERVICE MANUAL en Q is Level 1 H 1000 Fluid Warmer H 1000 100V Manufacturer Smiths Medical ASD Inc 160 Weymouth Street Rockland MA 02370 USA USA Canada 1 800 258 5361 International 1 781 878 8011 Made in U S A www smiths medical com P N 4533801 Rev 001 Level 1 H 1000 Operator s amp Service Manual About This Manual Purpose Concept System Features Filter with Gas Vent Temperature Control Flanking I V Pole Brackets Unpacking and Set up System 1000 Hardware Power and Alarm Test Panel Display Panel Interlocks Accessories System 1025 Pressure Infusers Set up and Use Disposables Set up and Performance Setting Up Disposable Sets Priming Disposable Sets Filter with Gas Vent Replacement in IV Disposable Sets Trouble Shooting Trouble Shooting Slow Flow Rates Testing Add Water Alarm Check Disposables Alarm Water Over Temperature Alarm Alarm Testing Performance Testing Earth Leakage Ground Continuity Dialectric Strength Maintenance Maintenance and Testing Log Service Warranty Service Non Warranty Service Specifications Physical Specifications Electrical and Environmental Specifications Accessory Maintenance and Calibration Part Numbers Parts and Electrical Schematics International Symbols No part of this manual may be reproduced in any form without prior written permission from Smiths Medical ASD Inc
17. V pole mount set up This versatile workstation features flanking side poles for Level 1 pressure infusers syringe pumps or infusion pumps Unpacking and Set up The H 1000 packaging should contain the following items Contents Quantity H 1000 Warming Unit H 1000 I V Pole Base H 1000 I V Bag Hanger H 1000 I V Pole with Flanking Brackets Il Accessory Pack H 1000 Manual D Series Instruction Card Y Connector Black Pneumatic Tubing Hex Wrench Il 1 Place the base upright on its wheels Lock casters to prevent pole movement during set up 2 Remove the three threaded pole screws on the vertical base tube Slide the I V pole with flanking brackets down over the vertical base tube lining up the three screw holes in the pole with the three screw holes in the base as shown in Figure 2 Note the flanking brackets should face the longer side of the base 3 Thread the three pole screws back through the holes at the base of the pole and tighten 4 Attach the H 1000 warming unit to the flanking brackets by sliding the eight threaded screws on the back of the unit into the eight keyhole notches on the flanking I V pole brackets Refer to Figure 2 Tighten all eight screws to secure warmer to I V pole and flanking brackets 5 Lock I V bag hanger into place on the top of the I V pole 6 Close the drain valve seen in Figure 7 on the bottom of the unit Remove the fill port plug on the front o
18. e alarm will sound With the unit running the interlocks may be tested one at a time by following these simple steps 1 Top Heat Exchanger Socket Slide up slowly two yellow indicators will illuminate and the audible alarm will sound 2 Heat exchanger interlock Gently pull on the middle of the heat exchanger one yellow indicator will illuminate and the audible alarm will sound 3 Filter holder interlock Remove the Filter with Gas Vent one yellow indicator will illuminate and the audible alarm will sound 17 Water Over Temperature Alarm Press and hold the Water Over Temperature alarm test button on the power and test panel on the front of the unit The display will jump to 45 C as long as the button is pressed on and the red over temperature indicator will illuminate and the audible alarm will start to pulse NOTE The Water Over Temperature Alarm test button actually tests the over temperature circuitry of the system not just the visible red display indicator and the audible alarm NOTE Pressing the Water Over Temperature test button or the Alarm test button will disable the H 1000 even after the buttons have been released The unit must be shut off and then re started to clear the alarm condition Alarm Testing The audible alarm and all indicator lights may be tested by pressing the Alarm test button on the power and test panel on the front of the cabinet NOTE Pressing the Alarm test button or the Water Over Tempera
19. f the unit and fill the tank with 1 4 liters of distilled water Replace the fill port plug chad jf Figure 2 H 1000 assembly CAUTION Tap water will increase earth leakage current For proper system operation and component life use only DISTILLED WATER in the water reservoir 7 Plug the unit into the appropriate electrical outlet See specifications for details CAUTION This device must be assembled and tested by Smiths Medical technical personnel an authorized distributor of Smiths Medical or a trained biomedical engineer prior to placing the device into service Refer to the Testing section of this manual for complete system testing instruction H 1000 Hardware The H 1000 has an onboard water supply heated to 41 7 C This temperature controlled water supply is rapidly circulated through the heat exchanger of the disposable set Two independent circuits continuously control and monitor water temperature and will shut the system down and alarm in the event of an over temperature condition Power and Alarm Testing The power and alarm test panel on the front of the H 1000 cabinet is shown in Figure 3 below It contains four membrane switches Only a gentle press is required to activate each switch 1 POWER 0N The green switch on the left powers ON the H 1000 warming unit including the onboard compressor for the pressure infuser accessory system 2 POWER
20. igure 1 Block diagram of Level 1 fluid warmers Figure 1 diagrams the H 1000 and its operation An onboard pump circulates warm water through the aluminum heat exchanger in the disposable set Note that the circulating water bath and the infusate flow against each other or counter current which maximizes heat transfer This diagram describes the essence of all Level 1 fluid warmers Filter with Gas Vent Level 1 D Series Disposable Sets employ a unique hands off Gas Vent which vents micro bubbles of gas that are always released from fluids as they are warmed In many other warming systems these micro bubbles are actually delivered to the patient along with the warmed fluids The Filter with Gas Vent assembly in the I V Sets contains a 170 micron screen filter to trap macro aggregates found in blood products This filter has luer lock connections and can be easily changed without patient disconnection or repriming of the entire disposable set The Filter with Gas Vent should be changed every three hours or when the filter becomes clogged whichever comes first Temperature control The H 1000 employs a safe circulating water heating system inherently free of any hot spots The primary temperature control circuit sets the circulating water bath to a temperature of approximately 42 C for efficient heat exchange and maximum fluid warming Flanking I V Pole Brackets The sturdy design of the H 1000 offers a compact custom I
21. ly for a part of EQUIPMENT Mains are connected Earth Potential Protected against dripping water Type BF Equipotentiality This symbol is located next to the ground stud on the back of the unit 28 Attention consult accompanying documents Collect separately for electrical and electronic equipment Ld NOTES 29
22. n sterile not for patient use D series disposable set with heat exchanger and filter assembly must be in place WARNING Do not attempt to defeat the disposable sensing interlocks or try to operate the H 1000 without a disposable in place Water may spill from the unit if the interlocks are defeated CAUTION Prior to placing the H 1000 into service the device must be tested by Smiths Medical technical personnel an authorized distributor of Smiths Medical or a trained biomedical engineer Periodic testing and maintenance should be performed by a biomedical engineer or trained personnel NOTE Refer to Maintenance and Testing Log section of this manual for safety testing frequencies and intervals Add Water Alarm The H 1000 is equipped with a float switch which senses the water level in the onboard reservoir When the water level is too low a yellow indicator on the display panel illuminates and an audible alarm sounds In the alarm condition the pump will not circulate water With a test disposable set in place the ADD WATER alarm may be tested by turning the drain valve on the bottom of the unit 90 degrees clockwise and allowing water to drain out into a container Drain until the water level falls below the minimum mark on the water tank Check Disposables Alarm Three interlocks sense a properly installed heat exchanger If a heat exchanger is not in place and the power switch is ON a yellow indicator will illuminate and an audibl
23. not properly seated the yellow light next to it will illuminate Make sure that the water tank is filled above the minimum mark level Fill or top off the tank with DISTILLED water only Turn off the power switch to clear the alarm Turn on the power switch again If the unit continues to alarm remove it from service for repair Make sure that the air inlet on the bottom of the unit is not blocked or clogged with dust Lubricate the O Rings in heat exchanger 1 and 2 sockets with silicone Order Part 80 04 002 to replace O Rings 15 Trouble Shooting Slow Flow Rates Many factors which are insignificant in low fluid administration are restrictors of higher flow infusion If you encounter flow restriction with any Level 1 Fluid Warmer CHECK EACH OF THESE POSSIBLE CAUSES OLD BLOOD Stored blood begins to develop particulate within 5 to 7 days This may partially block fluid pathways impeding flow FULLY SPIKED BAG Bag port membranes may only be split not completely pierced BAG PORT FILTER if used 40 micron to 80 micron filters used between the blood bag and the bag spike of the Disposable set may restrict flow because 1 Cold viscous blood does not flow well through small pore filters 2 As they are directly connected to the source of particulate with no pre filtering they clog quickly 3 They may trap air which can block filter media surface area CLAMPS PARTLY ENGAGED Check
24. ollowed correctly can cause improper results and damage to the equipment Messages that are headed by NOTE indicate information or procedures that if not followed correctly can cause improper results Purpose The Level 1 H 1000 fluid warmer has been designed for safe rapid in line warming of I V fluids as they are administered to patients Disposable sets designed for warming at various infusion rates are available Blood and l V solutions may be infused through the Level 1 I V Sets and will be delivered near 40 C High flow capacity warm fluid delivery simple operation and continuous on board safety systems make the H 1000 the ideal choice for all procedures requiring routine to rapid infusion of normothermic fluids Typical uses of the system include blood and solution warming during elective surgery in the I C U the Emergency Room and in Trauma Concept The H 1000 fluid warmer consists of a reusable hardware device and a single use disposable set Similar to extracorporeal warming technology found in the heart room warmed water is rapidly circulated through a disposable anodized aluminum tube to warm fluids as they are delivered to the patient The use of a thermal conductor rapid warm water circulation and counter current flow all contribute to the high warming capacity of the H 1000 System features Circulating water bath Heat flow Exchanger Heater Pump F
25. overall 48 inches 122cm Width overall 13 inches 33cm Depth overall 10 inches 26cm Weight assembled dry 20 pounds 9kG Distilled water capacity 0 37 Gal 1 4L Air source pressure 300 mmHg 24 Electrical Specifications Input Voltage 100 VAC Operating Frequency 50 60 HZ Operating Current 12 Amps Auxiliary outlet 1 5 Amps Temperature Set Point 41 7 C x 0 3 C Over Temperature Set Point 43 9 C x 0 1 C Environmental Specifications Temperature Humidity Operation 10 C 45 C 30 75 Transport 0 C 70 C 30 75 Storage 0 C 70 C 30 75 This product may be a potential biohazard Handle and dispose of in accordance with accepted medical practice and applicable regulations Accessories and replacement parts H 2 Pressure Infusers 7204012 O Ring kit 8004003 Thermal Calibration Well 8003002 D Series Calibration Thermometer D Series TempCheck DSTA 40 8001040 Parts and Electrical Schematics H 1000 Electrical Parts List is provided on the pages that follow and electrical Schematics are provided on pages 30 to 33 Questions or requests for additional information may be faxed to your authorized distributor or the Smiths Medical Technical Service Department at 1 781 878 8201 U S A or by calling Smiths Medical Technical Service Department at 1 781 878 8011 U S A Any service performed on this unit not authorized by Smiths Medical technical personnel or by an authorized distributor of Smiths Medical
26. rrent testing should be performed with the immersion heater circuit in the full ON condition In order to be sure the heater circuit is in a full ON condition testing should be performed on units which have been allowed to stand at room temperature and have room temperature water in the water reservoir before the unit is turned ON The H 1000 warms up quickly test readings must be taken within 1 minute of startup A steel stud is positioned on the back of the unit for earth leakage testing Units not meeting this standard should be returned to Smiths Medical or an authorized distributor of Smiths Medical for service 19 Ground continuily The H 1000 must be tested according to IEC 601 1 clause 18 A steel stud is positioned on the back of the unit for ground continuity testing Units not meeting this standard should be returned to Smiths Medical or an authorized distributor of Smiths Medical for service Dielectric strength The H 1000 must be tested according to IEC 601 1 clause 20 Units not meeting this standard should be returned to Smiths Medical or an authorized distributor of Smiths Medical for service Maintenance CAUTION Periodic maintenance and testing should be performed by a bio medical engineer or trained personnel NOTE Refer to Maintenance and Testing Log section of this manual for maintenance and safety testing frequencies and intervals EVERY USE 1 CLEAN EXTERIOR Clean the entire H 1000 or H 1025 with a spra
27. serve pressure gauge to ensure 300 mmHg approx is achieved NOTE The pressure is not adjustable on this device The fluid warmer power switch must be ON for pressure chambers to operate To Unload 1 Push toggle switch all the way over to the or OFF position This will release pressure in the chamber and deflate bladder 2 Open door and remove fluid bag 11 NOTE Chamber pressure must be released before the pressure chamber door can be opened To Clean Please refer to the maintenance section of this manual for complete cleaning and disinfecting procedures for the H 1025 pressure infusers Disposables Set up and Performance WARNING Refer to D series disposable packaging for complete set up and priming instructions indications contraindications warnings cautions and additional product information Setting Up Disposable Sets Level 1 D series disposable sets have been designed to be highly effective and easy to use in combination with the H 1000 fluid warming hardware By following the simple 1 2 3 blocks found on the H 1000 fluid warmer properly trained users can confidently have the system safely set up and operating within seconds Following the numbers found on the H 1000 1 Push the bottom end of the heat exchanger into the bottom heat exchanger 1 socket Be sure the heat exchanger is fully seated WARNING Do not bend heat exchanger Bending the heat exchanger may damage the inner aluminum tube
28. ss to engage the mating velcro strips 20 For external disinfecting a 10 bleach distilled water solution may be used CAUTION Do not autoclave Do not use alcohol abrasive cleaning agents or solvents Do not immerse any part of the H 1025 in liquids 2 GENERAL INSPECTION Visually check the condition of the device Remove any unit from service which shows physical damage or one in which the test disposable set does not install easily EVERY 30 DAYS 1 CHANGE DISTILLED WATER Drain the water by turning the drain valve shown in Figure 6 clockwise 90 degrees Drain until the tank is completely empty Close the drain valve remove the fill port plug on the front of the cabinet and refill the water reservoir with distilled water Replace the fill port plug Drain Valve Fan Guard Auxiliary Outlet Figure 6 Bottom view of H1000 Shows location of Drain valve Fan filter guard and Auxiliary outlet 2 LUBRICATE O RINGS Place a small amount of silicone lubricant on a cotton swab or the end of a finger and apply all around the O Rings in the bottom and top heat exchanger sockets It is not necessary to disassemble the sockets to lubricate them 21 EVERY 12 MONTHS 1 REPLACE O RINGS Remove the O Rings by pulling them out of the bottom and top sockets with a pair of needle nose pliers or by prying them out with a small screwdriver Lubricate the new O Rings and then press them into place 2 CLEAN FAN FILTER Remove
29. t the chamber door is closed and latched when pressure is activated With the Level 1 pressure infusion chambers properly installed the H 1000 fluid warmer becomes the H 1025 a complete fluid management system To Load In order to help avoid inadvertent infusion of air to the patient the following warnings should be observed WARNING Remove all air from solution bags WARNING Not for use with commercial I V solution bags less than 1 liter with air WARNING Not for use with autotransfusion bags 1 Set up and prime Level 1 D Series disposable V fluid warming set following the instructions on disposable package 2 Flip toggle switch on top front of the H 2 chamber all the way over to the or OFF position 3 Open chamber door by swinging out hinged latch on right side 4 Hang air free solution bag on door post NOTE Each pressure chamber can hold either a 500 ml bag or a 1000 ml bag For a 500 ml bag the hanging post is located on the inside of the door For a 1000 ml bag the post is located on the top of the door For optimum drainage of 1 liter bags the upper molded post is for longer style bags The lower molded post is used for standard size bags 5 Close door and secure side latch To Pressurize CAUTION Be certain latch is secure before chamber is pressurized Never pressurize with door open CAUTION Do not exceed 300 mmHg 1 Push toggle switch all the way over to or ON position Ob
30. the holder while still connected to the disposable set 3 Install the new filter assembly into the 3 holder 4 Using aseptic technique disconnect upper luer lock fitting and after removing upper male luer end cap from the new filter connect the set to the new filter inlet 5 Holding the used filter horizontally disconnect the lower patient line luer lock Connect the used filter luer lock fittings together and discard 6 With the filter outlet tube clamped open the clamps above the filter The filter with gas vent will self prime 7 Slowly release the outlet tube clamp and allow the outlet tube to fill completely 8 Remove the second luer lock end cap and connect the outlet tube luer lock to patient line 9 Remove the filter with gas vent from its holder and tap it against the cabinet several times until all trapped air bubbles have been vented out Return the filter to its holder Note The CHECK DISPOSABLE alarm will be activated whenever the filter with gas vent assembly is removed from its 3 holder 14 Trouble Shooting PROBLEM No Power Check Disposables Alarm Add Water Alarm Water Over Temperature Alarm Hot cabinet Difficult to Install Heat Exchanger THINGS TO CHECK Make sure that the unit is plugged in and the power switch is ON Is it plugged into correct circuit Make sure the heat exchanger and filter are properly installed and the top 2 socket is down If the top 2 socket is
31. ture test button will disable the H 1000 even after the buttons have been released The unit must be shut off and then re started to clear the alarm condition Performance Testing Periodic testing of the overall operating efficiency of the H 1000 can be accomplished in one of two simple ways 1 COLD START TEST NOTE This performance test requires a non sterile not for patient use Level 1 D series disposable set to be installed properly on the H 1000 Store the H 1000 unit in a room where the room temperature is approximately 21 C 70 F With a non sterile D series disposable set in place note the time and then turn the power switch ON The green OPERATING indicator will illuminate Rapidly rising numbers will appear on the circulating water bath temperature display A 41 C temperature reading will appear in approximately 3 to 7 minutes on an efficiently operating unit NOTE If the H 1000 does not pass the cold start test it should be returned to Smiths Medical or an authorized distributor of Smiths Medical for service Do not attempt to change the calibration settings 2 THERMAL CALIBRATION WELL TCW Available from Smiths Medical a TCW may also be used to test performance and confirm proper calibration of the water bath temperature 18 NOTE Use of the TCW requires a digital thermometer NIST traceable and accurate to within 0 1 C Required probe size 0 099 OD maximum 0 25 cm 0 50 1 50 long 1 27 3
32. y of warm soapy water solution or a commercial non abrasive cleaner and a soft cloth after every use Cold sterilizing solutions may be used but strong chemical concentrations may discolor some of the plastics on the device Do not use cleaning agents containing abrasives NOTE The H 2 pressure chambers can be partially disassembled for cleaning if needed a To remove the door open the door and push the door up to compress the spring and lift bottom end of door out of he slot b To remove the latching hinge open the latch and pop out of the slot c To remove the air bladder pull top of bladder away from housing The bladder is attached with velcro Disconnect the pneumatic fittings attached to the bladder valves To disconnect the fittings depress the ring closest to the bladder The bladder is now disconnected from the housing Ensure the fitting and attached air lines remain accessible d To reassemble latch place the latch evenly into the slot then pop latch into place e To reassemble door slide hinge pin at top of door into the hole until spring is fully compressed Next slide bottom hinge pin of door into the hole of channel f To replace the air bladder press the large bladder valve into the 1 2 straight union pneumatic fitting and the tubing attached to the small bladder valve into the 1 4 straight union pneumatic fitting Tuck the fittings inside of the enclosure Align bladder with the pressure chamber depression and pre
Download Pdf Manuals
Related Search