Level 1 H-1200 115V, H-1200 230V User manual

®

l®

Level 1® H-1200

Fast Flow Fluid Warmer

With:

H-31, Version B, Air Detector/Clamp

<H-1200 115 V

<H-1200 230 V

OPERATOR’S MANUAL

P/N 40-6917-51A

s

S E C T I O N X • T i t l e

ii	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

G e nSeEr Ca Tl I OI nN f oX r m• aT ti it ol ne

General Information

Level 1® H-1200 Fast Flow Fluid Warmer

Part Number: 40-6917-51A

This revision supercedes all previous revisions.

Under copyright laws, this manual may not be reproduced in any form, in whole, or in part, without prior written permission of Smiths Medical ASD, Inc. (Smiths Medical).

Smiths Medical and Level 1 design marks and Level 1 are trademarks of Smiths Medical. The symbol ® indicates the trademark is registered in the U. S. Patent and Trademark office and certain other countries. All other names and marks mentioned are the tradenames, trademarks, or service marks of their respective owners.

Every effort has been made to ensure that the information in this

manual is accurate and details provided are correct at the time of printing. The company, however, reserves the right to improve the equipment shown.

Mention of third-party products is for informational purposes only and constitutes neither an endorsement nor a recommendation. Smiths Medical assumes no responsibility with regard to the performance or use of

these products.

For further information, please call your local Smiths Medical distributor or Smiths Medical direct at 1 800 258 5361 or [phone].

©2014 Smiths Medical. All rights reserved.

H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

iii

C o n t e n t s

Contents

1 About this Manual	1
2 Description	3
3 Indications for Use	4
4 Important Safety Information	5
CONTRAINDICATIONS	5
WARNINGS	5
CAUTIONS	8
5 Out of the Box – Assembly	9
Step 1 – Verify Components of the Level 1® H-1200 Fast Flow Fluid Warmer	10
Step 2 – Assemble I.V. Pole to the Warming Unit	11
Step 3 – Install the Pressure Chambers	12
Step 4 – Attach the I.V. Bag Hanger	13
Step 5 – Disinfect the Recirculating Solution Reservoir	13
Step 6 – Preliminary Preparation	14
Step 7 – Connect the Pneumatic Tubing	14
Step 8 – Install the Level 1® H-31, Version B, Air-Detector/Clamp	15
Step 9 – Perform Electrical Safety Tests	17
6 Principle of Operation	19
Fluid Warming	19
Pressurized Fluid Delivery	19
Air Detection/Clamping	19
7 Controls and Displays	20
Fluid Warmer Power and Alarm Test Panel	21
Fluid Warmer Display Panel	22
Reservoir Level Display	22
Pressure Chamber Control Panel	24
Interlocks	25
8 Operation	27
Modes of Operation	28
OFF Mode	28
ON/Automatic Operation Mode for Fluid Warmer	28
Alarm Test Mode	28
Over Temperature Test Mode	29
Temperature Display	29
Check Disposables Mode	29
Add Recirculating Solution Mode	30
Over Temperature Alarm Mode	30
Power ON Test for Air Detector/Clamp	31
Automatic Operation Air Detector/Clamp	31
Check Tubing Mode	31
Air Detected/Clamped Mode	32
Pressure Display	32
Pressurized Mode	32
Unpressurized Mode	32

iv	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

C o n t e n t s

9 Operating Instructions	33
WARNINGS	34
9.1 Set Up for Use	34
A – Install the Disposable Administration Set	34
B – Prime the Disposable Administration Set	35
C – Prime the Patient Line	37
D – Test the Audible and Visual Alarms	37
E – Test the Air Detector/Clamp	38
9.2 Use of the Fluid Warmer	39
Step 1—Load the Pressure Chambers	40
Step 2—Pressurize the Pressure Chambers	40
Step 3—Make Patient Connection	40
Step 4—Replace the Gas Vent/Filter Assembly	40
Step 5—Change the Fluid Bag	41
9.3 Replace the Gas Vent/Filter Assembly	41
9.4 Activated Alarms	42
9.5 After Use	44
10 Troubleshooting	45
General Troubleshooting Guide	45
Slow Flow Rate Troubleshooting	46
11 Testing	47
Add Recirculating Solution Alarm	47
Check Disposables Alarm	47
Over Temperature Test	48
Fluid Warmer Alarm Signal Test	48
Performance Testing	48
Cold Start Test	48
Calibration Test	49
Calibration Test with DSTA-40	49
Proper Calibration of Recirculating Solution Temperature	49
Periodic Electrical Testing	50
Earth Leakage	50
Ground Continuity	50
12 Maintenance	51
Maintenance Performed Prior to Every Use	51
Clean the Exterior	51
General Inspection	52
Maintenance Performed Every 30 Days	52
Lubricate O-Ring Seals	52
Change Recirculating Solution with Distilled Water	53
Maintenance Performed Every 12 Months	53
Disinfect the Recirculating Solution Reservoir	53
Change Recirculating Solution with a	53
0.3% Hydrogen Peroxide/Distilled Water Solution
Change O-Rings	54
Clean Fan Filter	54
Inspect Air Detector/Clamp	54
Inspect the Reservoir and Float Switch Assembly	54
Testing Fluid Warmer Operation	54
Maintenance and Calibration Log	55
Scheduled Maintenance and Calibration Checklist	55

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v

C o n t e n t s

13 Limited Warranty	56
14 Service	58
Non-Warranty Work	58
Additional Documentation	58
Disposal Information	58
Service Contacts	59
15 Specifications	60
System Specifications	61
Standard Compliance	61
Physical	61
Environmental	61
Thermal	61
Electrical	61
Electromagnetic Environment Recommendations	61
Disposable Administration Set Specifications	61
DI-50	61
D/DI-60HL	61
D/DI-70	62
D/DI-100	62
D/DI-300	62

16 Symbols

Index

63

66

vi	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

S E C T I O N 1	•	A b o u t t h i s M a n u a l

S E C T I O N

1

About this Manual

WARNING: These instructions contain important information for safe use of the product. Read the entire operator’s manual, including Warnings and Cautions, before using this product. Failure to properly follow warnings,

cautions and instructions could result in death or serious injury to the patient.

This Operator’s Manual describes the set-up, use, and maintenance of:

•Level 1® H-1200 Fast Flow Fluid Warmer

•Level 1® H-1000 Fast Flow Fluid Warmer with H-2 Pressure Chambers (H-1025)

•Level 1® H-1000 Fast Flow Fluid Warmer with H-2 Pressure Chambers and H-31, Version B, Air Detector/Clamp

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” apply to the H-1000 Fast Flow Fluid Warmer except where indicated by the symbols defined in the following table.

Symbol			Description
			Appears in the margin to identify information that
			only applies to the H-1200 Fluid Warmer and the H-1000
			Fluid Warmer equipped with the H-31, Version B,
			Air Detector/Clamp
			Appears in the margin to identify information that only
			applies to the H-1000 Fluid Warmer (not equipped with
			the H-31, Version B, Air Detector/Clamp)

Conventions Used in this Manual

This manual uses the following text and text conventions:

	Convention	Description
	CONTRAINDICATION	A Contraindication statement alerts the user to
		conditions when the device should not be used.
	WARNING	A Warning statement alerts the user to conditions that
		may cause death or serious injury to the patient or user.
	CAUTION	A Caution statement alerts the user to conditions that
		may cause malfunction, failure, or damage to the device.

H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

1

S E C T I O N	1 • A b o u t t h i s M a n u a l

This manual is organized into the following sections:

2 and 3 Description and Indications for Use

These sections provide the purpose and indications for use of the Level 1® H-1200 Fast Flow Fluid Warmer.

4Important Safety Information

Lists the Contraindications, Warnings, and Cautions associated with the use of the Level 1® H-1200 Fast Flow Fluid Warmer.

5Out of the Box—Assembly

Guides the user through the installation of the Level 1® H-1200 Fast Flow Fluid Warmer and the Level 1® H-31, Version B,

Air Detector/Clamp.

6Principle of Operation

Provides a functional description of the Level 1® H-1200 Fast Flow Fluid Warmer.

7Controls and Displays

Provides a description of the function and purpose of the controls, displays, and indicators for the Level 1® H-1200 Fast Flow Fluid Warmer.

8Operation

Describes Operation, Indicator, and Alarm modes of the Level 1® H-1200 Fast Flow Fluid Warmer.

9Operating Instructions

Describes the Set Up, Use, and Alarm modes of the Level 1® H-1200 Fast Flow Fluid Warmer.

10Troubleshooting

Contains information on troubleshooting the Level 1® H-1200 Fast Flow Fluid Warmer. This section also details troubleshooting slow fluid flow rates.

11Testing

Describes Operational, Performance, and Electrical Tests that are used to verify the proper operation of the Level 1® H-1200 Fast Flow Fluid Warmer.

12Maintenance

Regular maintenance procedures for every use, 30-day, and 12-month intervals are covered in this section.

13Limited Warranty

Describes the Limited Warranty and its provisions.

14Service

Explains Non-Warranty Work as well as listing Service Contacts.

15Specifications

Provides physical, environmental, and electrical specifications of the Level 1® H-1200 Fast Flow Fluid Warmer.

16Symbols

Lists the symbols and their definitions used with the Level 1® H-1200 Fast Flow Fluid Warmer.

2	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

S E C T I O N	2 • D e s c r i p t i o n

S E C T I O N

2

Description

The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) is an I.V. fluid warmer with pressure chambers, air detection, and automatic clamping capability. I.V. fluid and/or blood products are warmed through the use of a sealed heat exchanger through which a recirculating solution flows. Pressure Chambers apply pressurization and deliver the fluids at a fast flow rate. This non-invasive method employs single-use, disposable administration sets that include a Gas Vent/Filter Assembly and Heat Exchanger.

The Air Detector/Clamp monitors for the presence of air in the disposable Gas Vent/Filter Assembly. When air is detected in the Gas Vent/Filter Assembly, the Air Detector/Clamp closes off the patient line and alerts operators to the presence of air with audible and visual alarms. An ultrasonic signal continually passes through the fluid filled Gas Vent/Filter Assembly. As a bolus of air displaces the fluid in the Gas Vent/Filter Assembly, the ultrasonic signal is broken and the clamp closes, stopping the air before it enters the patient line. Audible and visual alarms are activated, notifying the user that the fluid flow has stopped. 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 fourstep sequence that corresponds to numbered blocks on the device. Disposable Sets available for use on the Level 1® H-1200 Fast Flow Fluid Warmer are listed below.

•DI-50

•D-60 / DI-60HL

•D-70 / DI-70

•D-100 / DI-100

•D-300 / DI-300

D-series Disposable Sets are for use in the U.S.A. DI-series Disposable Sets are for use in markets outside of the U.S.A.

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3

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

3

Indications for Use

The Level 1® H-1200 Fast Flow Fluid Warmer (Fluid Warmer) provides a rapid flow of warmed fluids, such as crystalloid or blood product,

including red blood cells, as volume replacement for patients suffering from blood loss due to trauma or surgery.

The Fluid Warmer provides fast flow of warmed fluid to re-warm patients during surgery by trained medical personnel.

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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

S E C T I O N

4

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

Not for use in warming platelets, cryo-precipitates, or granulocyte suspensions.

WARNINGS

Death or serious injury may occur to the patient or user if these warnings are not followed:

•These instructions contain important information for safe use of the product. Read the entire operator’s manual, including Warnings and Cautions, before using this product. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient or user.

•Remove all air from the fluid bags before spiking and the fluid lines before connecting to the patient. Failure to do so can result in infusion of air into the patient.

•Replace Gas Vent/Filter Assembly every three hours, or when the filter becomes clogged, or when air is slowly vented. Failure to do so will result in a reduction of flow rate. This may result in inadequate patient treatment

•The replacement Gas Vent/Filter Assembly must be fully primed before continuing infusion. Failure to do so may allow air to be infused into the patient.

•Do not use the Fluid Warmer in high-energy fields such as:

MRI, X-RAY, portable and mobile RF communications equipment, and other such devices. The Fluid Warmer may act as a projectile in a strong magnetic field, cause image artifacts, or not function as intended.

•Do not bend the heat exchanger. Bending may damage the heat exchanger allowing communication between the recirculating solution and I.V. fluid path, resulting in the I.V. delivery of inappropriate fluids.

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5

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]

•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.

•When injecting medications into the fluid path, do not inject through the triple lumen tubing of the D/DI-60HL Disposable Set. This may allow communication between the recirculating solution and I.V. fluid path.

•Exposed conductor on MAINS power cord can cause an electrocution hazard. Remove device from service if MAINS power cord has exposed wires.

•Do not re-use partially full fluid bags. Fluid bags that have been partially drained, un-spiked, and then reinstalled may contain air, which if used can result in infusion of air into the patient. Use only new fluid bags from which the air has been removed.

•Activation of the Over Temperature warning signal indicates that warming has stopped and immediate operator intervention is required. Failure to clear the over temperature condition or to take the device out of service may result in death or serious injury to the patient.

•The Fluid Warmer is not for use with irrigating tubing, which may not fit into the clamp slot of the Air Detector/Clamp causing diminished flow or a failure to stop flow.

•The Fluid Warmer is for use only with Smiths Medical supplied or approved parts, accessories, and D or DI series Disposable Sets. The device may not function as intended with the use of unapproved parts, accessories, or Disposable Sets.

•Grounding reliability can only be achieved when MAINS power cords are connected to a properly grounded receptacle. Risk of electrical shock exists if the equipment is not connected to a properly grounded receptacle.

•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. Immediately stop transfusion, and follow institution’s protocol for treatment of transfusion reactions.

•Do not operate the Fluid Warmer in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. The risk of

6	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

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]

explosion exists if the Fluid Warmer is operated in a potentially explosive environment.

•No user-serviceable parts. All service must be performed by Smiths Medical or competent personnel.

•Disposable Sets are supplied with a sterile fluid path which may be compromised if the caps are not in place. Do not use Disposable Set if Luer and spike caps are not securely in place, or if Luer connections are not secure as the fluid path may not be sterile and may cause death or serious injury to the patient.

•Disposable Sets are for single use only. To reduce the risk of cross contamination, do not reuse Disposable Sets.

•If fluid exits the Patient Line of the D/DI-60HL Disposable Set, replace the Disposable Set.

•Do not use auto-transfusion bags. Auto-transfusion bags

may contain air that can result in infusion of air into the patient.

•Set-up, priming, and use require aseptic technique. Failure to use aseptic technique may result in death or serious injury to the patient.

•Do not use the Fluid Warmer if equipment or Disposable Set malfunction is evident.

•No modification of this equipment is allowed.

WARNINGS for the Air Detector/Clamp

•The tubing must be properly placed in the Clamp Slot of the Air Detector/Clamp. Failure to ensure that the tubing is correctly positioned in the Clamp Slot may result in failure to stop air infusion.

•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. Failure to reinstate flow (after purging any air or foam) may result in death or serious injury to the patient.

•Do not turn OFF the Fluid Warmer when the Air Detector alarm is active. If the Fluid Warmer is powered OFF in an active alarm state, the Air Detector/Clamp will open and the Air Detector will become disabled. This could allow any air within the patient line to be delivered to the patient resulting in serious injury

or death.

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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]

•The functional test for the Air Detector/Clamp accessory must be performed before each use. 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. Fully functional visual and audible alarm systems are essential for the safe use of the Air Detector/Clamp.

CAUTIONS

Malfunction, failure, or damage to the device may occur if these cautions are not followed:

•Never use organic solvents (e.g., acetone), strong acids, or bases to clean any portion of the Fluid Warmer.

•Do not place the Fluid Warmer directly under a faucet or use a faucet sprayer to rinse. Never spray cleaning or other fluids into openings on the Fluid Warmer or into the external connectors.

•When loading fluid bags into Pressure Chambers, choose a hanging hook that allows the bag port to hang freely in the indented slot at the bottom of the chamber door. If bag ports are positioned above this slot, diminished flow could occur.

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

•Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.

8	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

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

S E C T I O N 5

Out of the Box—Assembly

This device must be assembled and tested by authorized Smiths Medical personnel, an authorized distributor of Smiths Medical, or competent personnel prior to placing the device into service.

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® H-1000 Fast Flow Fluid Warmer.

Step 1 Verify components of the Fluid Warmer Step 2 Assemble I.V. Pole to Warming Unit Step 3 Install Pressure Chambers

Step 4 Attach the I.V. Bag Hanger

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

Read through the instructions completely prior to setting up the device.

Note: After unpacking the system, recycle packaging material according to hospital policy for recyclable materials.

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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

Note: The Level 1® H-31, Version B, Air Detector/Clamp is shipped as a separate accessory only for installation on an existing Level 1® H-1000 Fast Flow Fluid Warmer.

Check the contents of all packaging to verify that the following components are present. If any parts are missing or damaged, do not use the Fluid Warmer. Do not substitute parts not supplied by Smiths Medical. Contact Smiths Medical for replacement parts. Below is a listing of the component parts for the Level 1® H-1200 Fast Flow Fluid Warmer.

Components Checklist Qty Component

2

in order of appearance in illustration

Pressure Chambers / Contents:

(2) “U” brackets

1

(4) Thumbscrews

I.V. Bag Hanger

1

Fluid Warming Unit

1

H-31, Version B, Air

1

Detector/Clamp

Accessory Pack

(3) Pan-head screws

(3) Power Cord Clips

1

(3) Flat-head screws

Operator’s Manual

1

Quick Reference Guide

1

I.V. Pole with Flanking Brackets

1

Accessory Pack / Contents:

(2) Plastic “J” Clamps

(1) Y Connector

(1) Black Tubing

1

(1) Hex Wrench

O-Ring Kit / Contents:

(1) Silicone

(2) O-Rings

(1) Hex Wrench

3

(1) Instructions for Use

Bolts

3

Washers

1

I.V. Pole Base

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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. The steps are: 1. Assemble the I.V. Pole to the Base,

2. Close the Drain Valve, and 3. Attach the Warming Unit to the Flanking Brackets. Each step is detailed in a short procedure.

2.1 Assemble the I.V. Pole to the Base

1Locate the I.V. Pole Base (a).

2Locate the dark-gray extruded I.V. Pole (b) with Flanking Brackets.

b3 Place the I.V. Pole Base upright on its wheels, (c) and lock the wheels to prevent movement during set up.

		4	Locate three bolts (d) and washers for the
	d		pole base.
		5	Align the three holes (e) in the I.V. Pole with the three screw
	e		holes on the pole base.
		6	Slide the I.V. Pole down over the pole base, (f) keeping holes
	f		aligned.
		7	Guide three bolts and washers through the holes (g) at the base
			of the pole and tighten.
	g	a

c

	2.2 Close the Drain Valve
h	Turn valve, located on the bottom of the device, perpendicular
	to stem (h) of the Warming as shown.

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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

1Align the eight hex screws on the back of the Warming Unit with the eight keyhole notches on the flanking bracket.

2Slide screw heads down into keyhole notches.

3 Tighten all eight hex screws with the supplied hexwrench and secure in place.

2.4 Attach the Quick Reference Guide

to the Fluid Warmer by sliding the ring on the Quick Reference Guide over one of the poles on the Flanking Bracket.

Step 3 – Install the Pressure Chambers

1 Locate the two Pressure Chambers.

2 Locate the U-brackets and thumbscrews supplied with the Pressure Chambers.

3 Attach the U-brackets with thumbscrews to the back of the Pressure Chambers, as shown. Keep thumbscrews and brackets loose.

4 Slide one Pressure Chamber with attached U-bracket over the top of each flanking pole.

5 Align the U-bracket slightly below the top of the flanking pole. Tighten the thumbscrews securely.

12	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual

a

2	c

R

b

1

X

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

1Slide the I.V. Bag Hanger on top of the I.V. Pole.

2Align with tabs.

3Press down and snap into place.

Step 5 – Disinfect the Recirculating

Solution Reservoir

1Remove the fill-port plug (a) on the reservoir.

2Prepare a 0.3% hydrogen peroxide/distilled water solution for the reservoir. Mix 140 ml of 3% hydrogen peroxide solution and 1,260 ml of distilled water.

3Fill the reservoir with 1.4 liters of 0.3% hydrogen peroxide/ distilled water solution.

4Replace the fill-port plug.

5Insert a Disposable Set into the Fluid Warmer.

6Insert the power cord into a properly grounded receptacle.

7Turn the Fluid Warmer ON. Let the solution circulate for a 30-minute disinfection period.

8Turn the Fluid Warmer OFF.

9Empty the reservoir.

10Remove the Disposable Set and discard according to established hospital procedures.

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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

1Remove the fill-port plug (a) 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:

•0.3% Hydrogen Peroxide/Distilled Water Solution Mix 140 ml of 3% hydrogen peroxide and 1,260 ml of distilled water.

Note: If this option is selected, the maintenance requirement to change the recirculating solution is once every 12 months. Always use a 0.3% hydrogen peroxide/distilled water solution when refilling the reservoir.

•Distilled Water

Note: If this option is selected, the maintenance requirement to change the recirculating solution is once every 30 days.

2Replace the fill port plug.

3Lubricate O-Rings in #1 Block (b) and #2 Block (c). Place a small amount of silicone lubricant, provided in the supplied O-Ring Kit, on a cotton swab and apply all around the inside of each O-Ring.

2

c

R

b

a	1

Step 7 – Connect the Pneumatic Tubing

1Locate the Accessory Pack with the black pneumatic tubing (a), two “J” clamps (b), and one “Y” Connector (c).

a

b

c

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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

f

e

g

h

d

2 Locate the orange protective plug in the red ring connector (d) located on the back of the device. Remove the plug by depressing the red plastic ring as you pull the plug out of the connector.

3Take the pneumatic tubing and press one end of the tubing firmly into the ring connector (d) until it can go no further.

4Take the “Y” connector and press the other end of the pneumatic tubing into the bottom of the “Y” connector, as shown (e), until it can go no further.

5Press the pneumatic tubing from the Pressure Chamber into place

(f) on the top of the “Y” connector until it can go no further. Repeat this procedure with the pneumatic tubing from the other Pressure Chamber.

6Remove the protective backing sheet on one “J” clamp, exposing the adhesive side.

7Carefully position the “J” clamp and press the adhesive side against the gray I.V. Pole in the approximate locations (g)(h) shown.

Press down firmly to secure in place.

Repeat this procedure for the other “J” clamp.

8Press the pneumatic tubing into place on the “J” clamps.

Step 8 – Install the Level 1® H-31, Version B, Air-Detector/Clamp

F1
	F1
Two Fuse Configuration	Four Fuse Configuration

Before installing the Air detector, determine if the Fluid Warmer was manufactured before 2004. If it is, inspect the“F1” fuse to confirm that it is the correct value and type. The year of manufacture can be determined by the serial number label which is located on the bottom right side of the unit, or for older units on the inside. If the first four characters of the serial number are numbers, then

the numbers represent the year of manufacture (e.g. 20040100 would be manufactured in 2004). If the first character of the serial number is the letter“J”, then the year of manufacture is prior to 2004 (the letter“S” indicates the year 2007 or later). For units manufactured prior to 2004, perform the following.

1Disconnect the power.

2Remove the 18 screws from the rear of the Fluid Warmer and remove the back panel.

3Locate the “F1” fuse on the electronic assembly. See figures to locate the “F1” fuse for either a two fuse configuration or a four fuse configuration.

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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

• For 100 - 120V Fluid Warmers,

Remove the fuse and verify that T6.3AL250V (time lag, 6.3 amp, 250V fuse), is printed on one of the silver end caps, if not replace the fuse with a new fuse marked T6.3AL250V.

• For 220 - 240V Fluid Warmers,

Remove the fuse and verify that T3.15AL250V (time lag, 3.15 amp, 250V fuse), is printed on one of the silver end caps, if not replace the fuse with a new fuse marked T3.15AL250V.

4 Replace the back panel and insert all but 6 of the screws (a) as indicated in Step 1 below. Then proceed to install the Air Detector/Clamp.

To install the Air Detector/Clamp,

1Remove 6 screws (a) from the rear of the Fluid Warmer, lower left side, from locations shown in figure.

2Plug in the power cord (b) of the Level 1® H-31, Version B, Air Detector/Clamp into the auxiliary MAINS outlet located on the bottom of the Fluid Warmer.

Note: If you turn the Fluid Warmer off and the Air Detector/Clamp does not turn off, contact Smiths Medical or your local Smiths Medical distributor.

3 Loosen the three screws holding the mounting bracket to the	b
rear of the Air Detector/Clamp (do not remove).

a

d

a

a

e

a

e

a

e

a

4 Align the slot on the Air Detector/Clamp with #3 Block on the Fluid Warmer (c). Fit in place over the block.

Note: Do not bend the mounting bracket while holding the Air Detector/Clamp against the fluid Warmer.

5 Carefully align the mounting bracket on the rear of the
Air Detector/Clamp with three screw holes, shown (d).
Ensure that the gasket seal on the Air Detector/Clamp is
flush with the Fluid Warmer. Insert three flat-head screws
and tighten, securing the Air Detector/Clamp to the
	c
Fluid Warmer. Tighten the three screws on the
mounting bracket on the Air Detector/Clamp.

6 Locate three power cord clips (e) included with the Air Detector/Clamp and snap onto power cord. Align clips with the three screw holes as shown, insert screws, and tighten.

7 Install and prime a Level 1® Fast Flow I.V. Disposable Administration Set, and test the audible and visual alarms and Air Detection/Clamp as described in Section 9 Operating Instructions.

16	H-1200 FAST FLOW FLUID WARMER | Operator’s Manual