Read 4533099 Rev-003 [OM].qxd text version

INSTRUCTIONS FOR USE

and Preventative Maintenance

-

Level 1® HOTLINE® 2 Fluid Warmer

HL-290

Manufacturer: Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370, USA USA/Canada: 1-800-258-5361 International: +1-781-878-8011

Australian Representative: Smiths Medical Australasia Pty. Ltd. 61 Brandl Street Eight Mile Plains, QLD 4113, Australia Tel AU: +61 (0) 7 3340 1300 Tel NZ: 0 800 444 200

European Representative: Smiths Medical International Ltd. Colonial Way Watford, Herts, WD24 4LG, UK Tel: +44 (0) 1923 246434 www.smiths-medical.com

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Made in U.S.A. P/N 4533099 Rev. 003

INSTRUCTIONS FOR USE

HOTLINE®2 WARMER (REF HL-290)

Table of Contents

ABOUT THIS MANUAL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 INDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 TYPICAL INFUSATE DELIVERY TEMPERATURES . . . . . . . . . . . . . . . . . . . .3 DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 HOTLINE®2 WARMER: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 HOTLINE®2 WARMING SET: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 CONTRAINDICATIONS: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 WARNINGS: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 ELECTRICAL SAFETY: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 POWER REQUIREMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 ELECTRICAL SAFETY TESTING: . . . . . . . . . . . . . . . . . . . . . . . . . .5 STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 PREPARATION AND SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 INSTRUCTIONS FOR USE: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8 DISINFECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 TEMPERATURE VERIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . .10 RECOMMENDED MAINTENANCE CHECK LIST . . . . . . . . . . . . . .11 LIMITED WARRANTY SECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12 SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 PHYSICAL SPECIFICATIONS: . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 ELECTRICAL SPECIFICATIONS: . . . . . . . . . . . . . . . . . . . . . . . . . .13 OPERATING SPECIFICATIONS: . . . . . . . . . . . . . . . . . . . . . . . . . .13 ENVIRONMENTAL SPECIFICATIONS: . . . . . . . . . . . . . . . . . . . . . .14 SERIAL NUMBER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14 SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15

NOTE: A revision date for these instructions is included for the user's information. In the event two years elapse between this date and product use, the user should contact Smiths Medical ASD, Inc. (Smiths Medical) to see if additional product information is available. Level 1, HOTLINE, 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. Revision Date: 2006/07

P/N 4533099 Revision 003

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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 HOTLINE®2 Fluid Warmer. Failure to properly follow warnings, cautions, and instructions could result in death or serious injury to the patient.

REFERENCES:

The L-Series Fluid Warming Set will be referred to as the HOTLINE®2 Warming Set.

INDICATIONS

The HOTLINE®2 Warmer is designed for use with the HOTLINE®2 Warming Set to warm blood and I.V. fluids and deliver them to the patient's access site at normothermic temperatures under gravity flow conditions.

PRINCIPLES OF OPERATION

The HOTLINE®2 delivers fluids and blood at normothermic temperatures at routine, gravity flow rates. All other fluid warming systems suffer from cool-down between the warmer and the patient connection. HOTLINE®2 overcomes this problem by providing active warming of the patient line all the way to the patient connection, protecting the patient line against exposure to cold and eliminating patient line cool-down. Active warming is achieved by jacketing the sterile patient I.V. line with a layer of precisely temperature controlled circulating warm water. An 8' (2.4m) HOTLINE®2 Warming Set allows blood and intravenous fluid to be delivered to the patient at normothermic temperature (37°C) at gravity flow rates from 50 to 4,250 mL per hour (0.8 ­ 71 mL per minute). The HOTLINE®2 Warmer and Warming Set are an integrated, highly effective design with unparalleled ease of use. Properly trained users can confidently and safely have the HOTLINE®2 set-up and operating within seconds. NOTE: The HOTLINE®2 Warmer must be used only with HOTLINE®2 Fluid Warming Sets. HOTLINE 2 (HL-290) I.V. Fluid and Blood Warmer Typical Infusate Delivery Temperatures at Patient End of L-270

41.9°C water bath setpoint temperature

44.0 42.0 40.0 38.0

Temperature (° C)

36.0 34.0 32.0 30.0 28.0 26.0 24.0 22.0 20.0

50 250 500 750 1000 1500 2000 2500 3000 3500 4000 4500 5000

Flow Rate (mL/hr)

10°C Infusate 20°C Infusate

Ambient Temperature Range: 19.5°C ­ 20.5°C

File #209.3

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DESCRIPTION

HOTLINE®2 WARMER:

An on board water supply is heated to 41.5°C and circulated through the HOTLINE®2 Warming Set. Electronic circuitry continuously monitors the water temperature. Circulating water temperature and visual alarms are indicated on the Display Panel on the front of the HOTLINE®2. A green LED illuminates and the "WARMING" message is displayed on this panel when the HOTLINE®2 is set-up and operating correctly.

HOTLINE®2 WARMING SET:

Single Use HOTLINE®2 Warming Sets are provided in single HOTLINE®2 packaging with Sterile Fluid Path. The connector on the HOTLINE®2 Warming Set engages a socket on the HOTLINE®2 Warmer. This is the only connection necessary to provide the warming function. The HOTLINE®2 Warming Set is easily disengaged from the HOTLINE®2 Warmer and discarded, or it may be used to continue subsequent unwarmed infusion.

SAFETY

The HOTLINE®2 employs a safe, circulating water-heating system, inherently free of "hot spots" to actively warm the patient line. The primary temperature control circuit limits the circulating water to a 41.5°C (± 0.5°C) set-point maximum. In the unlikely event of a malfunction of this circuit, a second "watch-dog" circuit will visually and audibly alarm and stop the circulating water pump if the temperature reaches 1.2°C above the set point. Fluid in the HOTLINE®2 Warming Set is never exposed to any damaging or dangerous temperatures while the HOTLINE®2 is operating. The HOTLINE®2 is manufactured and certified to be in compliance with UL 2601-1 and EN 60601-1.

MESSAGES:

Messages that are headed by "NOTE:" indicate information or procedures that if not followed correctly can cause improper results. Messages that are headed by "CAUTION:" indicate information or procedures that if not followed correctly can cause improper results and damage to the equipment. Messages that are headed by "WARNING:" indicate information or procedures that if not followed correctly can cause improper results, damage to the equipment, and serious patient harm.

CONTRAINDICATIONS:

· · · · · · Not for use in warming cryo-precipitates or granulocyte suspensions. Failure to follow warnings may result in patient injury or death. The HOTLINE®2 Warming Set is a Single Use device and is not intended for resterilization. Sterile Fluid Path. If caps are not in place, then sterility will be compromised. Set-up, priming and use require aseptic technique. Follow applicable hospital policies and procedures. Prime the circulating water path of the disposable warming set before connecting to the intravenous administration set. This is to confirm that there is not a breach between the circulating water path and IV path. If fluid exits the patient end before connecting to intravenous administration set, remove and replace warming set. All air must be removed from the intravenous fluid lines before connecting to the patient. Failure to do so may result in introduction of air to the patient, which may contribute to serious patient injury or death. Monitor intravenous fluid line to make sure it is air-free. Do not stick the HOTLINE®2 Warming Set tubing with needles, which will compromise integrity of the patient intravenous line. If a disposable with a breached circulating water path/IV path is used, then patient illness may occur because of the fluid warmer's circulating water entering the patient's blood stream. Do not use HOTLINE®2 in the presence of flammable anesthetics because of the risk of fire or possibility of explosion. Do not use HOTLINE®2 in high-energy fields such as: MRI, X-RAY, etc. HOTLINE®2 may act as a projectile in a strong magnetic field, cause image artifacts or not function as intended.

WARNINGS:

·

·

· ·

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CAUTIONS:

· · Federal Law (USA) restricts sale of this device to or on the order of a physician. Do not mount the HOTLINE®2 more than 42" (107cm) above the floor. For convenience 42" (107 cm) is indicated on the HOTLINE®2 line power cord by a mark. Mounting the HOTLINE®2 above 42" (107cm) may result in instability of the pole and tipping. Do not autoclave or immerse any part of the HOTLINE®2 in liquids, which may cause damage and improper functioning. Insure that the HOTLINE®2 pole clamp is screwed tightly onto the IV pole. Failure to securely mount the HOTLINE®2 onto the IV pole may cause the HOTLINE®2 to slide down the IV pole. Not for use with pressure devices generating over 300 mmHg. Pressure greater than 300 mmHg may compromise the integrity of the HOTLINE®2 Warming Set. NOTE: Hand pumps can generate over 1000 mmHg.

· · ·

ELECTRICAL SAFETY:

POWER REQUIREMENT

Most of the current drawn by the HOTLINE®2 is for the 300-Watt immersion heater. When the device is first turned on and the digital display shows rapidly rising temperatures below 41°C, the 300-Watt heater is in a full ON condition. Beyond approximately 40°C, the proportional controller cycles the heater ON/OFF with proportionally shorter ON times as the circulating water nears the 41.5°C set point.

ELECTRICAL SAFETY TESTING:

All testing and maintenance should be performed by qualified personnel. Safety testing is to be conducted on an annual basis. This involves earth leakage and ground continuity, which must be tested according to UL 2601-1 and EN 60601-1. NOTE: This device is equipped with disposable sensing interlocks. A HOTLINE®2 Warming Set is required to correctly operate the device and perform leakage current testing. Do not defeat the disposable sensing interlocks or try to operate the HOTLINE®2 without a Warming Set in place.

Earth leakage must be tested according to UL 2601-1 and EN 60601-1. Earth leakage current test should be performed with the immersion heater circuit in the full ON condition. For this reason, leakage current test should be performed on a HOTLINE®2 that has room temperature water in the water tank. Ground continuity must be tested according to UL 2601-1 and EN 60601-1. HOTLINE®2 is certified that it is in compliance with the European Communities Council Directive relating to Electromagnetic Compatibility (EMC): (89/336/EEC). Test methods and acceptance criteria as specified in EN 60601-1-2 demonstrate conformance.

STORAGE

Store in a cool dry place. Do not expose to extreme temperature. See Environmental Specifications for more details.

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PREPARATION AND SET-UP

HARDWARE:

WARNING: HOTLINE®2 should be tested by hospital biomedical personnel prior to placing it in service. All testing and maintenance should be performed by qualified personnel.

Step 1: CLAMP THE HOTLINE®2 SECURELY TO AN I.V. POLE.

CAUTION: Do not mount the HOTLINE®2 more than 42" (107cm) above the floor. For convenience, 42" (107cm) is indicated on the HOTLINE®2 line cord by a black mark. Mounting the HOTLINE®2 above 42" (107cm) may result in instability of the pole and tipping. CAUTION: HOTLINE®2 is cooled by convection. Be sure the air vents on the bottom and the back of the HOTLINE®2 are kept clear. CAUTION: Insure that the HOTLINE®2 pole clamp is screwed tightly onto the I. V. Pole. Failure to securely mount the HOTLINE®2 onto the I.V. Pole may cause the HOTLINE®2 to slide down the I.V. Pole.

Step 2: FILL THE WATER TANK

1. The water tank is located under the HOTLINE®2 Warmer. Remove the water tank by twisting it 1/4 turn clockwise. 2. Fill the water tank with 500 mL of distilled water or the 35% alcohol maintenance solution 3. Replace the water tank and twist counterclockwise to secure in place. 4. Plug the HOTLINE®2 into the applicable outlet (115V~ or 230V~). NOTE: Use Distilled Water only. Failure to use distilled water may cause mineral build-up in the circulating water path, which may impair heater performance. NOTE: If the unit does not heat to its set point temperature within *10 minutes remove unit from service. (* 10 minutes of operation without Infusate being heated.)

PREPARATION

To · · · · set up the HOTLINE®2 Warming Set you will need the following: HOTLINE®2 Warmer L-270 HOTLINE®2 Fluid Warming Set Intravenous fluid or blood Intravenous administration set

INSTRUCTIONS FOR USE:

NOTE: CAUTION: CAUTION: The picture on page 7 is a graphical representation of the following steps. Visually Inspect Warming Set tubing for kinks prior to use. If a leak is found during priming, remove the faulty warming set and install a new warming set.

Step 1: Set-up the HOTLINE®2 Warming Set

1. Insert the Warming Set Connector into the socket on the front of the HOTLINE®2 Warmer, lining up the arrow on the connector with the arrow on the HOTLINE®2 Warmer. Turn the connector to the right to lock into place.

Step 2: Activate the Power "ON" switch.

1. 1. The "SELF-TEST" message will appear in the display. All LEDs will light (green, yellow, and red) and the audible alarm will sound briefly. 2. Once the HOTLINE®2 has completed the start-up test procedure, the "PASSED SELF-TEST" message will display, followed by the "SET POINT" message which indicates the circulating water bath temperature. The "WARMING" message displays while in use. The green "OPERATING" LED will illuminate. The circulating water bath temperature, displayed in degrees Celsius, will begin to increase. The circulating water bath temperature display will reach 37°C in approximately 4 minutes. When HOTLINE®2 reaches it set point temperature it is ready to warm fluids.

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Step 3: Confirm Integrity of Tubing Set

1. The circulating water path will automatically prime when the HOTLINE®2 is turned on. Inspect the patient end of the tubing for leaks to confirm the integrity of the intravenous pathway. Using aseptic technique, connect the intravenous administration set to the HOTLINE®2 Warming Set. Fully prime the intravenous administration set and the HOTLINE®2 Warming Set. Aseptically, connect to the patient's intravenous access site without entrapping air. Adjust the rate of flow using the clamp on the intravenous administration set. 1. Depress the Power "OFF" switch. The "WAIT DRAINING" message will appear in the display while the HOTLINE®2 recaptures circulating water from the Warming Set tubing. When water recapture is complete the "REMOVE DISPOSABLE" message will display for 15 seconds and the HOTLINE®2 Warmer will shut down. Disconnect the HOTLINE®2 Warming Set by turning the connector to the left. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal regulations.

Step 4: Connect the Intravenous Administration Set

1. 2. 3. 4. 1. 2. 3. 4. 5.

After Use

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TROUBLESHOOTING

1. Alarms: Visual (red indicator LED) and Audible (pulsed alarm)

· Display reads "OVER TEMPERATURE": Indicates a malfunction of the temperature control system. No fluid warming is taking place. Depress the Power "OFF" switch and remove from service for repair or replacement. Display reads "WATER TANK LOW": Blinking message indicates that additional distilled water should be added to the HOTLINE®2 Water tank. Failure to use distilled water may impair heater performance. Display reads "FAILED SELF-TEST": Indicates that the HOTLINE®2 warmer has failed the Self-Test procedure. Depress the Power "OFF" switch and remove the HOTLINE®2 from service. Display reads "DISPOSABLE": Indicates that the HOTLINE®2 Warming Set is not properly installed and fluid warming is not taking place. Check Warming Set connector insertion. Display reads "ADD WATER": Indicates that additional distilled water or 35% alcohol maintenance solution must be added to the HOTLINE®2 Warmer water tank. No fluid warming is taking place. Depress the Power "OFF" switch, remove the water tank reservoir, fill with distilled water or 35% alcohol maintenance solution, replace and activate the Power "ON" switch. Failure to use distilled water may cause mineral build-up in the circulating water path, which may impair heater performance. Display reads "NOT WARMING": Indicates that warming is not taking place. Check for kinks in the tubing. If the problem persists, depress the Power "OFF" switch and remove the HOTLINE®2 from service.

2. Indicator: Visual (LCD)

·

3. Indicator: Visual (yellow indicator LED) and Audible (pulsed alarm)

· · ·

·

REMOVAL FROM SERVICE:

If any of the following conditions occur the HOTLINE®2 must be removed from service. · Failed Self-Test · Over Temperature Alarm is activated · IV Pole Clamp does not function correctly · Missing, misaligned, incorrect or incomprehensible characters on the LCD · Does not circulate or recapture water · Pumping water without disposable connected · Does not reach maximum set point temperature within 10 minutes (when not administering Infusate) · Does not power up or power down · Audible and Visual Indicators do not function · LCD characters do not change with respect to the HOTLINE®2 function or display wrong language.

MAINTENANCE

All testing and maintenance should be performed by qualified personnel.

EXTERNAL CLEANING: EVERY USE

For routine cleaning, use mild cleaning agents or 70% isopropyl alcohol and a soft cloth. For external disinfecting, a 10% bleach solution may be used. CAUTION: Do not autoclave or immerse any part of the HOTLINE®2 in liquids, which may cause damage and improper functioning

GENERAL INSPECTION: EVERY USE

Visually check the condition of the HOTLINE®2. Remove from service any HOTLINE®2 which shows physical damage or one in which the HOTLINE®2 Warming Set does not install easily.

CHANGE DISTILLED WATER: EVERY 30 DAYS

1. 2. 3. 4. Unplug the HOTLINE®2 before servicing. The water tank is located under the HOTLINE®2 Warmer. Remove the water tank by twisting it 1/4 turn clockwise. Empty the tank. Fill the water tank with 500 mL of distilled water or 35% alcohol maintenance solution, directions follow. Maintenance solution: 35% Isopropyl alcohol / distilled water solution: mix 250 mL of 70% Isopropyl alcohol and 250 mL of distilled water (this will equal 500 mL of fluid) Replace the water tank and twist counterclockwise to secure in place.

5.

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DISINFECTION: Every 30 Days

To 1. 2. 3. 4. disinfect the circulating water bath, the following procedure should be employed: Unplug the HOTLINE®2 before servicing. The water tank is located under the HOTLINE®2 Warmer. Remove the water tank by twisting it 1/4 turn clockwise. Empty the tank. Fill the water tank with 500 mL of: · A 35% Isopropyl alcohol / distilled water solution: mix 250 mL of 70% Isopropyl alcohol and 250 mL of distilled water (this will equal 500 mL of fluid)

These suggested instructions are designed to be used in conjunction with established hospital procedures. NOTE: Use Distilled Water only. Failure to use distilled water may cause mineral build-up in the circulating water path, which may impair heater performance. 5. 6. 7. 8. 9. 10. Replace the water tank and twist counterclockwise to secure in place. Insert a Warming Set into the HOTLINE®2. Activate the Power "ON" switch and let the solution circulate for 30 minutes. Depress the Power "OFF" switch, remove the tank and empty. Refill the reservoir tank with 500 mL of distilled water or 35% alcohol maintenance solution. Replace the water tank and twisting it 1/4 turn counterclockwise to secure in place.

TESTING

All testing and maintenance should be performed by qualified personnel. All testing should be performed annually or following Hospital protocol. NOTE: Indicator testing requires a HOTLINE®2 Warming Set to be installed and the HOTLINE®2 operating.

INDICATOR TESTING Add Water Indicator: The HOTLINE®2 is equipped with a float switch, which senses the water level in the water tank.

When the water is too low, the ADD WATER Indicator will activate.

To test the Add Water Indicator circuit:

Unplug the HOTLINE®2 before servicing. The water tank is located under the HOTLINE®2 Warmer. Remove the water tank by twisting it 1/4 turn clockwise. 3. Empty the tank, then refill the tank with approximately 200ml's of water and replace it. 4. Turn the unit on and observe the LCD, it will display the words "ADD WATER". 5. Observe that the green LED goes out. 6. The yellow ADD WATER LED will light. 7. The audible alarm will sound. 8. Water will stop circulating. 9. Remove the water tank; add approximately 75ml's of water. 10. Replace the water tank, turn the unit on and observe the LCD, it will intermittently display the words "LOW WATER LEVEL". Disposable Indicator: An interlock switch located in the Disposable Interface Block senses a properly installed Warming Set. When the switch does not sense a Warming Set the message "DISPOSABLE" will be displayed. 1. 2.

To test the Disposable Indicator circuit:

1. 2. 3. 4. 5. Slowly remove the HOTLINE®2 Warming Set from the HOTLINE®2. Observe that the green LED goes out. The message "DISPOSABLE" will be displayed. The audible alarm will sound. Water will be recaptured.

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TEMPERATURE VERIFICATION

All testing and maintenance should be performed by qualified personnel.

Displayed Circulating Water Temperature: Should be verified using a Level 1 TEMP CHECK Thermometer

(HLTA-20). Other methods of temperature verification may be inaccurate. HOTLINE®2 can be returned for temperature verification. Refer to the TEMP CHECK HLTA-20 Thermometer Operator's Manual that accompanies the HLTA-20 for complete Temperature Verification and Calibration Instructions.

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RECOMMENDED MAINTENANCE CHECK LIST

MODEL: HOTLINE®2 FLUID WARMER REF: HL-290

All testing and maintenance should be performed by qualified personnel. Write your date of purchase here _____________________ Write your serial number here _____________________ 30-day maintenance tasks

Change Distilled Water or 35% alcohol maintenance Solution

12 months maintenance tasks Verify Temperature/ Calibrate (see Temp Check Manual)

Alarm / Indicator Testing

Earth Leakage Test

Ground Continuity Test You may photo copy this form for your record keeping. Notes:

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LIMITED WARRANTY SECTION

LIMITED WARRANTY HOTLINE®2 Fluid Warmer Part No. HL-290

This HOTLINE®2 fluid warmer is warranted by Smiths Medical ASD, Inc. (Smiths Medical) to be free from defects in material or workmanship for a period of 1 year (12 months) from the date of shipment to the customer. If the Customer finds any HOTLINE®2 device to have such defects during this period, it should be returned to the address given below. At Smiths Medical's option, the product will either be repaired or replaced by a new machine and returned to the Customer. This Warranty will not apply in respect of any HOTLINE®2 product which does not have its original Serial Number plate intact. Nor will this warranty apply to any damage or defect caused by misuse of the product; by careless or deliberate mistreatment of the product; or by any impact to the product. In no event will Smiths Medical or its distributors be liable for any consequential or economic loss incurred by the Customer. The liability of Smiths Medical and its distributors for any defect in the HOTLINE®2 product will be limited to the invoice value of the product. This warranty does not affect any warranty or guarantee to which the Customer is irrevocably entitled by virtue of any applicable law. With that proviso, this Warranty replaces all other express or implied warranties, representations or indemnities to which the Customer may otherwise be entitled by virtue of any law, trade practice or otherwise.

SERVICE

CAUTION: All service must be performed and/or authorized by Smiths Medical or a Smiths Medical Distributor. Service by others voids the warranty and transfers liability for malfunctions of the device to the servicing organization. WARRANTY SERVICE HOTLINE®2 received for repair, which have not been obviously abused or impact damage and are still under Warranty will be promptly repaired and returned at no charge. A no-charge purchase order is requested for tracking. NON-WARRANTY WORK HOTLINE®2 received which have suffered obvious abuse or impact damage and HOTLINE®2 no longer under Warranty will be promptly inspected and a verbal estimate of repair cost will be given to you. A purchase order will be required from the hospital consistent with the verbal estimate. A written estimate will be provided upon request. Be sure that ALL water is drained from the HOTLINE®2 before packing it for shipment. NOTE: HOTLINE®2 must be cleaned and disinfected for repair shipment.

SERVICE CONTACTS: USA/Canada Smiths Medical ASD, Inc. 160 Weymouth Street Rockland, MA 02370 USA USA/Canada 1-800-258-5361 International +1-781-878-8011 European Representative Smiths Medical International Ltd. Colonial Way, Watford, Herts, WD24 4LG, UK Tel +44 (0) 1923 246434 Fax +44 (0) 1923 240273

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Australian Representative Smiths Medical Australasia Pty. Ltd. 61 Brandl Street Eight Mile Plains, QLD 4113, Australia Tel +61 (0) 7 3340 1300 Fax +61 (0) 7 3340 1399 New Zealand Tel 0 800 444 200

www.smiths-medical.com

SPECIFICATIONS

REF HL-290

If the HOTLINE®2 should encounter any electrical interference, either receiving or transmitting, move the HOTLINE®2 away from the device in question. Plug the HOTLINE®2 into a separate electrical circuit. If problem continues, notify Smiths Medical or your Smiths Medical Distributor for assistance.

PHYSICAL SPECIFICATIONS:

Electrical Classification: Class 1 Equipment, Type BF Height Length Width Weight dry Weight wet Weight, Shipping 9.5 inches (24.1 cm) 8.3 inches (21 cm) 7.0 inches (17.8 cm) 7.6 lbs. (3.5 Kg) 11.0 lbs. (5.0 Kg) 7.95 lbs. (3.6 Kg)

ELECTRICAL SPECIFICATIONS:

Input Voltage Operating Frequency Operating Current 115V~ 50-60 Hz 3.0A 230V~ 50-60 Hz 1.5A

OPERATING SPECIFICATIONS:

The Circulating Water Bath has a set point temperature of 41.5°C with an accuracy of ± 0.5°C. The temperature displayed has an accuracy of ± 1.0°C. Temperature Set point Range: (36.0 ­ 41.9°C) ±0.5°C Max. Height on I.V. Pole 42 inches (107 cm) This equipment was tested for compliance to UL 2601-1 and EN 60601-1.

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ENVIRONMENTAL SPECIFICATIONS:

Operation Transport Storage Temperature 10°C - 30°C -20°C - +40°C -20°C - +40°C

SERIAL NUMBER

REFERENCE NUMBER

REF HL-290 XXXV SN XXXX XXXX REV. ________________

SEQUENTIAL NUMBER SERIAL NUMBER YEAR OF MANUFACTURE SOFTWARE REVISION

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SYMBOLS

B

COLLECT SEPARATELY FOR ELECTRICAL AND ELECTRONIC EQUIPMENT

15

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