level 1 H-1200 115V Operator's Manual
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level 1 H-1200 115V Operator's Manual

Fast flow fluid warmer
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OPERATOR'S MANUAL
P/N 4533708GB Rev. 006
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  • Page 1 OPERATOR’S MANUAL P/N 4533708GB Rev. 006...
  • Page 2 | Operator’s Manual...
  • Page 3 Smiths Medical ASD, Inc. (Smiths Medical). Smiths Medical and Level 1 design marks and Level 1 are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.

  • Page 4: Table Of Contents

    Step 5 Disinfect the Recirculating Solution Reservoir Step 6 Preliminary Preparation Step 7 Connect the Pneumatic Tubing ® Step 8 Install the Level 1 H-31, Version B, Air Detector/ Clamp Step 9 Perform Electrical Safety Tests 6 Principle of Operation...
  • Page 5 C o n t e n t s 9 Operating Instructions Warnings 9.1 Set Up for Use A—Install Disposable Administration Set B—Prime the Disposable Administration Set C—Prime the Patient Line D—Test the Audible and Visual Alarms E—Test the Air Detector/Clamp 9.2 Use of the Fluid Warmer Step 1—Load the Pressure Chambers Step 2—Pressurize the Pressure Chambers...
  • Page 6 C o n t e n t s 13 Limited Warranty 14 Service Warranty Service Non-Warranty Work Additional Documentation Disposal Information Service Contacts 15 Specifications System Specifications Physical Environmental Thermal Electrical Electromagnetic Environment Recommendations Disposable Administration Set Specifications DI-50 and DI-55 D/DI-60HL and D/DI-65HL D/DI-70 and D/DI-75 D/DI-100 and D/DI-150...

  • Page 7: About This Manual

    The manual is intended for use by individuals trained in the healthcare and biomedical professions. This operator’s manual is also for users of the H-1000 Fast Flow Fluid Warmer. All references to the “Level 1 ® H-1200 Fast Flow Fluid Warmer”...
  • Page 8 Describes Operation, Indicator, and Alarm modes of the Level 1 ® H-1200 Fast Flow Fluid Warmer. 9 Operating Instructions Describes the Set Up, Use, and Alarm modes of the Level 1 ® H-1200 Fast Flow Fluid Warmer. 10 Troubleshooting Contains information on troubleshooting the Level 1 ®...

  • Page 9: Description

    Clearing the bolus of air and restoring the fluid flow are quickly accomplished without disconnecting from the patient. Disposable Administration Sets The installation, set up, and replacement of Level 1 ® Fast Flow I.V. Disposable Administration Sets (Disposable Sets) follows a four-step sequence that corresponds to numbered blocks on the device.

  • Page 10: Indications For Use

    S E C T I O N 3 • I n d i c a t i o n s f o r U s e S E C T I O N Indications for Use The Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) provides a...

  • Page 11: Important Safety Information

    I m p o r t a n t S a f e t y I n f o r m a t i o n S E C T I O N Important Safety Information This section covers information for prescribers and guidelines for safe use of the Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer). CONTRAINDICATIONS •...
  • Page 12 S E C T I O N 4 • I m p o r t a n t S a f e t y I n f o r m a t i o n WARNINGS [continued] • Do not bend the heat exchanger. Bending may damage the heat exchanger allowing communication between the recirculating solution and I.V.
  • Page 13 S E C T I O N 4 • I m p o r t a n t S a f e t y I n f o r m a t i o n WARNINGS [continued] • Use of a bedside leukocyte reduction filter may cause a sudden precipitous drop in blood pressure resulting in respiratory distress, facial flushing, abdominal pain and nausea, and loss of consciousness.

  • Page 14: Cautions

    S E C T I O N 4 • I m p o r t a n t S a f e t y I n f o r m a t i o n WARNINGS for the Air Detector/Clamp [continued] •...

  • Page 15: Out Of The Box-Assembly

    The following steps describe how to assemble and do preliminary set up of the Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer). Refer to Step 8 if you need to install the Level 1 ® H-31, Version B, Air Detector/Clamp to the Level 1 ®...

  • Page 16: Step 1 Verify Components

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y Step 1 ® Verify Components of the Level 1 H-1200 Fast Flow Fluid Warmer The Level 1 ®...

  • Page 17: Step 2 Assemble I.v. Pole To Warming Unit

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y Step 2 Assemble I.V. Pole to the Warming Unit There are three steps involved in assembling the I.V. Pole to the Warming Unit.

  • Page 18: Step 3 Install The Pressure Chambers

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y 2.3 Attach the Warming Unit to the Flanking Brackets 1 Align the eight hex screws on the back of the Warming Unit with the eight keyhole notches on the flanking bracket.

  • Page 19: Step 4 Attach The I.v. Bag Hanger

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y Step 4 Attach the I.V. Bag Hanger 1 Slide the I.V. Bag Hanger on top of the I.V. Pole. 2 Align with tabs.

  • Page 20: Step 6 Preliminary Preparation

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y Step 6 Preliminary Preparation Remove the fill-port plug ( ) on the front of the warming unit and fill the reservoir to the maximum level with 1.4 liters of one of the following solutions: •...

  • Page 21: Step 8 Install The Level 1 ® H-31, Version B, Air Detector Clamp

    Repeat this procedure for the other “J” clamp. Press the pneumatic tubing into place on the “J” clamps. Step 8 Install the Level 1® H-31, Version B, Air Detector/Clamp Before installing the Air detector, determine if the the Fluid Warmer was manufactured before 2004.

  • Page 22: H-31, Version B, Air Detector/Clamp

    ) from the rear of the Fluid Warmer, lower left side, from locations shown in figure. ® Plug in the power cord ( ) of the Level 1 H-31, Version B, Air Detector/Clamp into the auxiliary MAINS outlet located on the bottom of the Fluid Warmer.

  • Page 23: Step 9 Perform Electrical Safety Tests

    S E C T I O N 5 • O u t o f t h e B o x — A s s e m b l y Install and prime a Level 1 ® Fast Flow I.V. Disposable...
  • Page 24 S E C T I O N 6 • P r i n c i p l e o f O p e r a t i o n H-1200 H-1200 | Operator’s Manual...

  • Page 25: Principle Of Operation

    S E C T I O N 6 • P r i n c i p l e o f O p e r a t i o n S E C T I O N Principle of Operation The schematic illustration on the facing page depicts the Level 1 ® H-1200 Fast Flow Fluid Warmer’s (Fluid Warmer) operations.

  • Page 26: Gas Vent/Filter Assembly

    S E C T I O N X • T i t l e F-50 Gas Vent/Filter Assembly The DI-55, D/DI-65HL, D/DI-75, D/DI-150, and D/DI-350 Disposable Administration Sets contain the F-50 Gas Vent/Filter Assembly. The F-50 GasVent/Filter Assembly utilizes a float assembly contained in a fluid chamber to prevent air from entering the patient line.

  • Page 27: Controls And Displays

    S E C T I O N Controls and Displays Five locations on the Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) govern how the device is controlled and where function indicators are displayed. They are called-out in the figure and are defined in the list below.

  • Page 28: Fluid Warmer Power And Alarm Test Panel

    S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s Fluid Warmer Power and Alarm Test Panel The Power and Alarm Test Panel is located on the front of the Fluid Warmer directly above the reservoir fill-cap.

  • Page 29: Fluid Warmer Display Panel

    S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s Fluid Warmer Display Panel The Fluid Warmer Display Panel provides continuous information about the operation of the Fluid Warmer.

  • Page 30: Air Detector/Clamp Control Panel And Alarms

    S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s Air Detector/Clamp Control Panel and Alarms The Air Detector/Clamp Control Panel has three LED indicators that display the operational state of the Air Detector/Clamp.

  • Page 31: Pressure Chamber Control Panel

    S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s Pressure Chamber Control Panel The Pressure Chamber Control Panel uses a control lever to switch from pressurized to unpressurized mode.

  • Page 32: Interlocks

    S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s Interlocks The Fluid Warmer has five Interlocks that detect for proper installation of a Disposable Set’s components.
  • Page 33 S E C T I O N 7 • C o n t r o l s a n d D i s p l a y s | Operator’s Manual...
  • Page 34 S E C T I O N 8 • O p e r a t i o n | Operator’s Manual...

  • Page 35: Operation

    S E C T I O N 8 • O p e r a t i o n S E C T I O N Operation The Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) performs three primary functions; Fluid Warming, Air Detection/Clamping, and Pressurized Fluid Delivery.

  • Page 36: Modes Of Operation

    S E C T I O N 8 • O p e r a t i o n Modes of Operation WARNING! If any visual indicator does not illuminate or the audible signal does not sound, do not use the Fluid Warmer. Remove the device from service immediately.

  • Page 37: Alarm Test Mode

    S E C T I O N 8 • O p e r a t i o n Alarm Test Mode The Alarm Test mode is used to test the visual and audible indicators of the Level 1 ® H-1200 Fast Flow Fluid Warmer. This mode is entered by pressing and holding the Alarm Test button ( ) on the Fluid Warmer’s...

  • Page 38: Check Disposables Mode

    S E C T I O N 8 • O p e r a t i o n Check Disposables Mode The Check Disposables mode of the Fluid Warmer indicates a missing or improperly installed Disposable Set. Mode characteristics • The Check Disposables yellow LED (a) on the Fluid Warmer’s Display Panel is illuminated.

  • Page 39: Over Temperature Alarm Mode

    S E C T I O N 8 • O p e r a t i o n Over Temperature Alarm Mode The Over Temperature Alarm mode is entered when the temperature of the recirculating solution reservoir is at or above 43.9°C WARNING! ctivation of the Over Temperature warning signal indicates that...

  • Page 40: Automatic Operation Air Detector/Clamp

    S E C T I O N 8 • O p e r a t i o n Automatic Operation Air Detector/Clamp In Automatic Operating mode, the Air Detector/Clamp monitors for the presence of air in the Disposable Set’s Gas Vent/Filter Assembly. If air is detected the patient line is clamped off and an audible alarm beeps.

  • Page 41: Air Detected/Clamped Mode

    S E C T I O N 8 • O p e r a t i o n Air Detected/Clamped Mode In this mode the Air Detector/Clamp is activated when the ultrasonic sensor detects the presence of air in the Gas Vent/Filter Assembly. Auditory and visual warnings are activated and the clamp is closed, preventing passage of fluid through the patient line.

  • Page 42: Unpressurized Mode

    S E C T I O N 8 • O p e r a t i o n To Exit this mode • Place the Pressure Chamber lever in the minus (–) unpressurized position ( Unpressurized Mode Disable pressurization by moving the lever on the Pressure Chamber to the minus (–) unpressurized position ( Mode characteristics •...

  • Page 43: Operating Instructions

    • When injecting medications into the fluid path, do not inject through the triple-lumen tubing of the Level 1® D/DI-60HL and D/DI-65HL Disposable Set. This may allow communication between the recirculating solution path and I.V. fluid path, which could result in death or serious injury to the patient.

  • Page 44: 9.1 Set Up For Use

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s 9.1 Set Up for Use WARNINGS • Read and follow all instructions, labeling, and accompanying documents supplied with this medical device.
  • Page 45 S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Move the pinch clamp on the Patient Line of the Gas Vent/Filter Assembly next to the Luer connector.
  • Page 46 S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Step 4 — H-1200 Fluid Warmer with DI-50, D/DI-60HL, D/DI-70, D/DI-100, and D/DI-300.

  • Page 47: B-Prime The Disposable Administration Set

    If bag ports are positioned above this slot, diminished flow could occur resulting in physical injury to the patient, user, and/or an adverse effect on the device or its performance. 5 Open clamp above Drip Chamber on Level 1 ® DI-50, DI-55, D/DI-60HL, D/DI-65HL, D/DI-70, and D/DI-75 Disposable Administration Sets for each I.V.

  • Page 48: C-Prime The Patient Line

    Disposable Set following the directions provided in Section 6 Controls and Displays , on Interlocks. C—Prime the Patient Line Remove the male Luer cap from the distal end of the Patient Line. On Level 1 ® D/DI-60HL and D/DI-65HL Disposable Note: Administration Sets verify that no recirculating solution comes out of the distal end of the Patient Line.

  • Page 49: D-Test The Audible And Visual Alarms

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s WARNING! If fluid exits in the Patient Line or the D/DI-60HL and D/DI-65HL Disposable Set, replace the Disposable Set.

  • Page 50: E-Test The Air Detector/Clamp

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Clear the Over Temperature alarm condition. • Turn the Fluid Warmer OFF, then ON. •...
  • Page 51 S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Conclusion This concludes Section 9.1, Set Up for Use. Operators can proceed to the next Section 9.2, Use of the Fluid Warmer.

  • Page 52: 9.2 Use Of The Fluid Warmer

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s 9.2 Use of the Fluid Warmer Use of the Fluid Warmer requires that the steps in Section 9.1, Set Up for Use have been completed.

  • Page 53: Step 5-Change The Fluid Bag

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s WARNING! Blood and blood products could contain pathogenic organisms. Failure to follow Institutional policy and procedures for biomedical-hazardous materials could lead to exposure to harmful pathogens which could result in user death or serious injury.

  • Page 54: Step 3-Make Patient Connection

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s 9.3 Replace the Gas Vent/Filter Assembly Use one of the following Gas Vent/Filters Assemblies: •...

  • Page 55: 9.4 Activated Alarms

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Remove the Gas Vent/Filter Assembly from the #3 Block used while still connected to the Disposable Set.
  • Page 56 S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s WARNING! • Activation of the Air Detector/Clamp Alarm during infusion indicates that fluid flow has stopped and that immediate operator intervention is required to restore fluid flow.

  • Page 57: 9.5 After Use

    S E C T I O N 9 • O p e r a t i n g I n s t r u c t i o n s Refer to Section 9.3, Replace the Gas Vent/Filter Assembly. 5 If no warning signals are active, the Fluid Warmer with Air Detection and Pressure Chambers is ready for use.

  • Page 58: Troubleshooting

    S E C T I O N Troubleshooting Only competent personnel should perform any routine maintenance and ® repairs to the Level 1 H-1200 Fast Flow Fluid Warmer (Fluid Warmer). The following two tables feature general troubleshooting information along with slow flow rate troubleshooting.

  • Page 59: Slow Flow Rate Troubleshooting Guide

    If this fails to correct problem, replace with new Gas Vent/ Filter Assembly. Non-high flow Use only extension lines with an inner diameter of ® extension lines 0.13" (3.3mm) or larger, such as Level 1 X-36 or Y-30 extension sets. ® Stopcock Use only Level 1 SC-3 (9 french inner diameter).

  • Page 60: Testing

    H-1200 Fast Flow Fluid Warmer (Fluid Warmer) and installed accessories do not pass the tests, discontinue use of the medical device and remove from service. Contact Smiths Medical or your local Smiths Medical distributor. Testing requires a Level 1 ® Disposable Administration Set (Disposable Set) to be installed in the Fluid Warmer.

  • Page 61: Over Temperature Test

    S E C T I O N 1 1 • T e s t i n g 3 Gas Vent/Filter Assembly Interlock – Pull the top of the Gas Vent/Filter Assembly from the Block. The Check Disposables indicator will illuminate and the audible alarm beeps. 4 #3 Check Tubing Interlock on the Air Detector/Clamp –...

  • Page 62: Performance Testing

    Calibration Test One approved way to confirm proper calibration of the recirculating ® solution temperature is to use the Level 1 Thermal Calibration Well (TCW) (Part Number 80-03-002). A replacement filter (F-10/30 or F-50) must be in place to utilize the TCW.

  • Page 63: Proper Calibration Of Recirculating Solution Temperature

    DSTA-40 temperature display stabilizes. 5 Compare the DSTA-40 temperature display with the temperature display on the Fluid Warmer’s Display Panel. Note: The Fluid Warmer’s temperature display must read within 0.3°C of the Level 1 ® DSTA-40 TEMPCHECK display on a properly calibrated unit.

  • Page 64: Periodic Electrical Testing

    S E C T I O N 1 1 • T e s t i n g Periodic Electrical Testing Earth Leakage The Fluid Warmer must be tested in accordance with EN 60601-1. The earth leakage current test should be performed with the immersion heater circuit in the full ON condition;...

  • Page 65: Maintenance

    S E C T I O N Maintenance Only competent personnel should perform any routine maintenance and repairs to the Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer). Maintenance is scheduled prior to each use, every 30 days, and annually. The tasks are detailed below.

  • Page 66: General Inspection

    S E C T I O N 1 2 • M a i n t e n a n c e 4 Rinse a separate soft cloth or sponge in room temperature running potable water. Squeeze out excess water so that the applicator is not dripping.

  • Page 67: Maintenance Performed Every 30 Days

    S E C T I O N 1 2 • M a i n t e n a n c e Maintenance Performed Every 30 Days Lubricate O-Ring Seals It is not necessary to disassemble the blocks to lubricate the O-Rings. 1 Place a small amount of silicone grease on a cotton swab.

  • Page 68: Change Recirculating Solution With 0.3% Hydrogen

    S E C T I O N 1 2 • M a i n t e n a n c e 9 Turn the Fluid Warmer ON. Let the solution circulate for a 30-minute disinfection period. 10 Turn the Fluid Warmer OFF. 11 Empty the reservoir.

  • Page 69: Inspect Air Detector/Clamp

    S E C T I O N 1 2 • M a i n t e n a n c e Inspect Air Detector/Clamp 1 Check Clamp Cover Door for proper closure. 2 Check the Clamp Cover Door, Clamp Slot and Detector Head for structural integrity.

  • Page 70: Maintenance And Calibration Log

    S E C T I O N 1 2 • M a i n t e n a n c e Maintenance and Calibration Log All maintenance and testing should be done by competent personnel. Regularly scheduled maintenance ensures proper functioning of the equipment.

  • Page 71: Limited Warranty

    Original Purchaser. THERE ARE NO OTHER WARRANTIES. This warranty does not cover normal wear and tear and maintenance items, and excludes any accessory items or equipment used with the Level 1 ® H-1200 Fast Flow Fluid Warmer.
  • Page 72 H-1200 Fast Flow Fluid Warmer. The Manufacturer shall not be responsible for any incidental damages or consequential damages to property, loss of profits, or loss of use caused by any defect or malfunction of the Level 1 ® H-1200 Fast Flow Fluid Warmer..

  • Page 73: Service

    A purchase order will be required from the original purchaser consistent with the verbal estimate. A written estimate will be provided upon request. Before returning your Level 1 ® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) or Level 1 ®...

  • Page 74: Disposal Information

    S E C T I O N 1 4 • S e r v i c e • Components parts list(s) • Description of function • Service and calibration instructions Disposal Information Observe national and local codes or requirements for disposal of contaminated materials and for recycling solid waste materials that may impact the environment.

  • Page 75: Specifications

    S E C T I O N 1 5 • S p e c i f i c a t i o n s S E C T I O N Specifications System Specifications Physical Measurement Height, Overall 67 inches (1.7 m) Width, Overall 20 inches...

  • Page 76: Electromagnetic Environment Recommendations

    S E C T I O N 1 5 • S p e c i f i c a t i o n s Electromagnetic Environment Recommendations Disposable Administration Set Specifications DI-50 and DI-55 Filter Size 170 Micron Priming Volume DI-50 56 ml DI-55...

  • Page 77: D/Di-70 And D/Di-75

    S E C T I O N 1 5 • S p e c i f i c a t i o n s Disposable Administration Set Specifications (continued) D/DI-70 and D/DI-75 Filter Size 170 Micron Priming Volume D/DI-70 70 ml D/DI-75 160 ml System 1200 Normothermic (35 –...

  • Page 78: Symbols

    S E C T I O N 1 6 • S y m b o l s S E C T I O N Symbols | Operator’s Manual...
  • Page 79 S E C T I O N 1 6 • S y m b o l s | Operator’s Manual...
  • Page 80 S E C T I O N 1 6 • S y m b o l s Symbol Meaning Alarm Test ON —Only for a part of the equipment. MAINS are connected OFF —Only for a part of the equipment. The MAINS are still connected Automatic Operation Recirculating Solution Temperature...

  • Page 81: Index

    I n d e x Add Recirculating Solution indicator 23 Description 3 Maintenance 59 Add Recirculating Solution Mode 32 Air Detector/Clamp 3 Every 12 months 61 After Use 51 Disposable Administration Set 3 Every 30 days 61 Air Detected Alarm mode Fluid Warmer 3 Log/Schedule 64 Clear 50...
  • Page 82 I n d e x Pressure gauge 25 Over Temperature test 55 Pressurize Pressure Chambers 46 Performance 56 Safety information 5 Pressurize/Unpressurize lever 25 Troubleshooting Service information 67 Pressurized Mode 35 General 52 contacts 68 Prime Slow flow rate 53 Set Up for use 38 Disposable Administration Set 41 Specifications 69...

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H-1200 230v

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