questions?contact records processed fda/cdrh/oce/did under ... · bath is heated with both heaters...

Records processed under FOIA Request 2018-345; Released by CDRH on 5/16/2018Questions?Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

NATIONAL _ MICROGRAPHICS H ASSOCIATION

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Records processed under FOIA Request 2018-345; Released by CDRH on 5/16/2018

Questions?Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118

Ut.fAKiA\hiN'i UbHLALiJbi &i. HUMAN SERVICES Public Health Service

AUG I 3 1981

Mr. Leonard Berke Vice President Cincinnati Sub-Zero Products 2612 Gilbert Avenue Cincinnati, Ohio 45206

Dear Mr. Berke:

Inc .

Food aad Drug Administration 8 7 5 7 Georgia Avenue Silver Spring MD 2 0 9 1 0

Ref: K811742/A - Hometherm,' Model'400

Dated: Ju ly 7, 1981 Received: -July 13,- 1981 Regulatory class: ^

^P

VJe have reviev/ed your premarket notification submission and have found the device to be substantially equivalent to devices introduced into interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. Ycu may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). This product has been placed into the regulatory class shown above by a final regulation published in the Federal Register. Class I devices are regulated by the general control provisions of the Act applicable to all medical devices including annual registration, listing- of devices, good manufacturing practices, labeling, and the misbranding and adulteration provisions of the Act; class II devices are those for which future performance standards will be developed; class III devices are those which will be required to undergo premarket approval at some time in the future.

Existing major regxilations affecting your device can be found in the Code of Federal Regulations, Title 21, Part 800. In addition, the Food and Drug Administration (FDA) may publish further announcements concernirig your device in the Federal Register. We suggest you subscrit>e to this publication so that you can convey your views to FDA if you desire. Also, the. Federal Register will notify you of any additional requirements subsequently imposed on your device. Subscriptions may be obtained from the-Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Such information also may be reviewed in the Dockets Management Branch (HFA-305), Food and Drug Administration, Room 4-62, 5600 Fishers Lane, Rockville, Maryland" 20857.

This letter does not in any way denote official FDA approval of your device or its labeling. Any representation that creates an impression of official approval of this device because of compliance with the premarket notification regulations is misleading and constitutes misbranding. If you need further assistance on the labeling for your device, please contact the Bureau of Medical Devices, Division of Compliance Operations, 8757 Georgia Avenue, Silver Spring, Maryland 20910.

Sincerely yours,

l/M-77, Robert S. Kennedy, Ph.D. Associate Director

for Device Evaluation Bureau of Medical Devices.



• 7/7 ui:.fntt.iiinru^J l Uf l-i;:ALTH & HUArATT^TTTVTCES

lem

• Date

From R e v i e w e r (s) . - -Name Cs)'

Subject 510 (K) N o t i f i c a t i o n

•The R e c o r d

7Î 177A - ^

It is my recommendation that the subject 510(K) Notification;

(A) Is substantially equivalent to marketed devices.

(B) Requires premarket approval. NOT substantially-equivalent to marketed devices.

(C) Requires .more data.

(D) Is an incomplete submission. (See Submission Sheet)

Additional Coraments: Class Code w/ Panel:

y/Dijy

REVIEW':' .

FINAL REVIEW; A7.y^ DATE

yi^7/ 'T'TISION DIRECT-©R DATE

OPTIONAL REV IEW ASSOC. DIRECTOR FOR DEVICE EVAL, DATE

i..i.-:-,f ••;*wî!\;;;.!.-»M;;-*'.!'îi-!'i^'-'«: ''.



osz mcinnati Sub-Zero

Cincinnati Sub-Zero Products, inc. 2612 Gilbert Avenue Cincinnati, Ohio 45206 (513) 751-8810

Cable: Sub-Zero, Cincinnati

July 7, 1981

F.D.A. Bureau of Medical Devices Document Control Center (HFK20) 8757 Georgia Ave. Silver Spring, MD 20910

Gentlemen:

Attn: 510K No. K811742

In accordance with your request, we are sending you, with this letter, the Operations part of our Operation & Technical Manual for the HMOTHERM Cooler/Heater Unit.

Contact us If you have any questions.

Yours very truly,

CINCINNATI SUB-ZERO P:0DUCTS7~I C-r><'

LB ab ends.

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Engineers and Manufacturers of Temperature and Environmental Control Equipment for Industry and Medicine



I

I HEMOTHERM I DUAL RESERVOIR COOLER/HEATER

1» OPERATION & TECHNICAL MANUAL

0S2 Cincinnati Sub-Zero

ICincinnati Sub-Zero Products, Inc.

2612 Gilbert Avenue, Cincinnati, Ohio 45206 (513) 751-8810

I H-681



TABLE OF CONTENTS

Section Paragraph Topic Page No.

GENERAL INFORMATION 1-9

n Function of HEMOTHERM Model WO Cooler/Heater ~ T 1.2 Cooling System 1 1.3 Heating System 2 l.'f Circulation System 2 1.5 General Operation 3-5 1.6 General Safety Precautions 6 1.7 Equipment Description and Specifications 6

Table 1.1 - HEMOTHERM System Equipment and Accessories 8 Table 1.2 - HEMOTHERM System Equipment Specifications 9

OPERATING INSTRUCTIONS 10-12

2TI Initial Set-up (first time only) W 2.2 Connection Procedure 11 2.3 Suggestions for Protecting Reservoir from Bacteria , 11 l.if. Built-in Safety Precautions 12

GENERAL MAINTENANCE AND REPAIR 13-20

3.1 General Instructions -Maintenance, Repair or Replacement of Components 13

3.2 Maintenance of Water Reservoirs 13 3.3 Maintenance of Condenser Grille i t 3.^ Maintenance of Blankets 1^ 3.5 Instructions for Replacing Heaters 15 3.6 Instructions for Changing Pump Housing 15 3.7 Calibration of the Differential for Controller 16 3.8 Calibration of High or Low Limit Thermostats 16 3.9 Replacing RTD Sensor 17 3.10 Replacing Control Panel 17 3.11 Replacing of the Manifold 18 3.12 Replacement of High or Low Limit Thermostats 18 3.13 Troubleshooting with the Copeland Compressor 19 3.1^* Instructions for Checking Microamperage Leakage 19 3.15 Suggested Preventive Maintenance Check List 20

TROUBLESHOOTING GUIDE 21-27

PARTS INFORMATION 28- ^^

5.1 Ordering Information for Replacement Parts 28 5.2 Recommended Replacement Parts Inventory 28 5.3 Returning Parts Under Warranty 29

Exploded Component Views and Parts Identification 30-39 Schematic Drawings and Flow Charts W-^t^



I 0 I I I I I I

1.1 Function of HEMOTHER^f'Model ^00 Cooler/Heater Equipment

The CSZ HEMOTHERM Model ^00 Cooler/Heater system is used to either lower or raise the blood temperature and/or maintain blood temperature, as re quired, through conductive heat transfer. The conductive heat transfer is accomplished through any type of Blood Oxygenator/Heat Exchanger unit, along with the use of a blanket under the patient for the rewarming phase, if desired. The complete system usually comprises the HEMOTHERM Cooler/

Heater unit and thermal blanket in either O.R. Table, Adult, or Pediatric size. Blankets are available in two (2) reuseable types: Herculite Staph-Chek (life expectancy 7-10 years) and plastic (polyurethane); as well as in a new disposable (vinyl) version.

The operator of the unit regulates the blood temperature desired. Frequent observation of the actual fluid temperature is required.

1.2 Cooling System

I I I I I I

The HEMOTHERM WO cooling system consists of:

1) A mechanically refrigerated water-to-refrigerant heat exchanger.

2) Chilled water reservoir.

3) Water recirculation pump.

^) Digital temperature control system.

5) Lo Temperature safety thermostat.

With a capacity to lower the water temperature at a 2 C./minute rate, a rapid reduction of blood temperature is produced. The recirculation pump and water flow circuitry have been designed for high flow rate to maximize the blood-to-water heat transfer efficiency.

The cooling system's temperature controller features an operator setable temperature range of +32 C. to 3°C.. An additional automatic temperature control provides the lo-limit safety function and is factory preset (at 2°C.).

• ^



1.3 Heating System

I I I I I I

The CSZ HEMOTHERM Treating system consists of:

1)

2)

3)

^ )

5)

6)

300 Watt Heater.

1200 Watt Heater.

Digital temperature system.

Heated water reservoir.

control

Water recirculation pump.

Hi temperature safety thermostat.

When in the cool mode, the 300 watt heater will pre-warm the heat bath to the desired temperature set for that reservoir, while in the heat mode, the bath is heated with both heaters or, 1500

watts of heat. The water temperature will increase at a rate of approximately 1.5°C./minute. It is important to remember that there is no direct relationship between this and the rate of change in the blood temperature.

The high limit thermostat is preset at the factory to shut off the heaters at 'f3°C.. If the controller should happen to fail at the 'f2°C. setpoint, a safety high temp warning light on the control panel will illuminate at ^3°C.. If this should occur, the system should be inspected by the hospital's maintenance or engineering department. The heating system wUl come back on after approximately a

temperature drop. 2°C

l.'f Circulation System

The HEMOTHERM system consists of:

'fOO circulation

1) Two water reservoirs steel.

stainless

2)

3)

f)

5)

6)

One heated water (7 qts. - 6.6 liters)

One cooled water (6.5 qts. - 6.2 liters)

One magnetic-drive recirculation pump.

Four water flow control valves - solenoid operated.

One pressure regulator.

Six external interfacing quick-disconnect couplings.

Interconnecting piping,internal.

Selection of operation mode (heat or cool) determines which water flow circuit is used. HEATING MODE: Pump

draws water from the warm water reservoir and circulates it to the external outlet couplings connected to the device in use (Blood Oxygenator/Heat Exchanger and/or blanket). Returning water flows back into the same (warm) water reservoir. COOLING MODE;Pump draws water from the cooled water reservoir and circulates it to the connected external device(s). Returning water flows back into the cooled water reservoir.

The circulation system operates with either distilled or tap water. NO alcohol or ethylene glycol (antifreeze) required. Flow rate capacity is as follows:

Thru 1/2" self-sealing Hansen fittings - approximately 5 GPM (19 liters/minute).*

Thru adult blanket - approximately 30 GPH (114 liters/hour).

* Flow rate will vary dependent upon brand and model number of heat exchanger used.

I I I I I I

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I

I I I I I I

1.5 General Operation

I I I i I I

1. Collect All Supplies & Equipment

A. HEMOTHERM™ Cooler/Heater unit, including connecting hoses to heat exchanger, making sure all connections are tight.

B. Hyper-Hypothermia blanket (optional). If the blanket was previously filled, check to make certain there are no leaks. Instructions for repairing the blanket can be found under Maintenance of Blankets (Paragraph 3.^).

DISPOSA-COVER blanket cover.

disposable

Place HEMOTHERM unit in O.R. suite, as close to heat exchanger as possible.

Read the operating instructions on the control panel, and familiarize yourself with the name and location of all features and controls shown in Figure 5.2.

Check level of distilled or tap water in both fluid reservoirs to make certain they are filled to 1" below the top of each reservoir. (Hot reservoir holds 7 qts., and the Cold reservoir holds 6-1/2 qts.) It is necessary to add a little water after each use to replace water thrown a.way in disposable heat exchanger and, Hyper-Hypothermia blanket, if disposable one was used.

Make sure the power and pump switches are both in the "OFF" position.

Inspect the hospital grade plug for bent or missing prongs. Insert the plug into a properly grounded, securely mounted receptacle. Grounding reliability can only be achieved when connected to an equivalent hospital grade receptacle. Do not bypass the third, or grounding prong. An electrical hazard may result if it is bypassed, removed, or otherwise rendered useless. If an extension cord is used, it also must be 3-wire, and of at least 14 gauge.

Lay the Hyper-Hypothermia blanket flat on the O.R. table, with hose attachment coming off the table as close as possible to where the HEMOTHERM unit will be placed. Cover the blanket with a CSZ DISPOSA-COVER, blanket.

sheet or, bath

Pre-condition your water reservoirs.

A. Press the selector switch to the COOL MODE position (which is the out position).

B. Turn on the power switch (selector switch should light up in blue on the cool mode side).

Wait 15 seconds pump switch.

turn on the

D. The temperature on the cool display is the present temperature of the water in the cool reservoir.

I I



1.5 General Operation (cont'd)

I

I I I I I I

E. Push the "COOL" setpoint knob in and read the temperature displayed. This is the setpoint temperature. To lower setpoint temperature, turn the knob counterclockwise, while depressing the setpoint knob and, to increase setpoint temperature, turn knob clockwise.

NOTE: The compressor will come on (indicated by the green pilot light marked "COMPRESSOR") if the setpoint temperature is lower than the actual water temperature in the cool reservoir. The compressor will shut off when the fluid temperature reaches, or falls below, the setpoint temperature. WARNING: Do not cool below 10 C. without having the pump running.

F. Set the "COOL" bath temperature at 3 C. to maximize blood cooling efficiency.

G. While in the cool mode, you can pre-warm your hot reservoir. Push the "HEAT" setpoint knob in and read the temperature displayed. This is the setpoint temperature. To lower setpoint temperature, turn the knob counterclockwise, while depressing the setpoint knob, and to increase the setpoint temperature turn knob clockwise. NOTE: The 300 watt heater will activate (indicated by the orange pilot light marked "LO HEATER") if the setpoint temperature is higher than the actual water temperature in the hot reservoir. The 300 watt heater will shut off when the fluid temperature reaches, or rises above, the setpoint temperature.

H. Set the warm bath at the tem-perviture desired when you start re-warming.

9. After the cold bath is pre-conditoned, then proceed to connect your heat exchanger to the 1/2" self-sealing Hansen fittings. NOTE: You may want to turn off the pump first if you choose not to circulate cool water through the heat exchanger.

10. Check physician's instructions to determine the desired cooling and heating temperatures.

11. At this point, you may choose to maintain normal body temperature (step 12), or you may choose to cool the blood (step 13).

12. Maintain normothermia by setting the desired temperature using the "HEAT" setpoint knob, pushing in the "HEAT" mode button, and making sure the pump is on. The "HEAT" temperature displayed is the fluid temperature circulating through the heat exchanger and the Hyper-Hypothermia blanket, if you choose to use one. NOTE: Both the 300 watt Lo Heater and the 1200 watt Hi Heater will cycle on and off to maintain the setpoint temperature.

13. Cool the blood by setting the desired fluid temperature using the "COOL" setpoint knob. We recommend 3 C. to maximize the cooling efficiency. Push in the "COOL" mode button and make sure the pump is on. The "COOL" temperature displayed is the fluid temperature circulating through the heat exchanger. NOTE: The compressor will cycle on and off to maintain the setpoint temperature.

I I I I I I

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I 0 I I I I I I

1.5 General Operation (cont'd)

I I I I I I

14. Maintain final hypothermia temperature by resetting the Cool set-point temperature to 10 C. and turning off the pump when you reach the hypothermia temperature desired. If the temperature should tend to rise, reactivate the pump, allowing the cool water to circulate through the heat exchanger and, as a result, bring the blood temperature down, again. NOTE: Pre-set your hot bath temperature to the desired initial rewarming temperature (as described in Paragraph 1.5, Section 8, Step G).

15. Re-warm by pushing in the "HEAT" mode button on the selector switch and resetting the setpoint temperature to the desired water temperature. Both the 300 watt Lo Heater and the 1200 watt Hi Heater will activate giving you a maximum of 1500 watts of heat to raise the hot bath fluid temperature to the set-point temperature. At this point, if desired, connect your hyper-hypothermia blanket to the 1/8"

Hansen fittings on the HEMO-THER/vr unit, to maximize rewarming efficiency.

16. If you happen to over-shoot your desired "COOL" bath temperature you may push the selector switch to the "HEAT" mode for 5 to 10 seconds, allowing the water in the water lines and heat exchanger to empty into the "HEAT" bath and fill up with warm water. Switching back to the "COOL" mode will allow the warm water in the water lines and heat exchanger to be dumped into the "COOL" bath, in turn warming the temperature of that bath a few degrees (1°-6°C.), depending on the difference in temperature between the two reservoirs. The same can be done if you over-shoot your desired hot bath temperature.

17. To discontinue operation simply turn off the power switch, and disconnect all lines leading to the heat exchanger and blanket from the HEMOTHERM unit.

I



1.6 General Safety Precautions

I

I I I I I I

If v/ater is found leaking into or around the HEMOTHERM unit prior to or during the operating procedure discussed here. Immediately disconnect power to the unit and correct the malfunction before proceeding.

Before performing any disassembly procedure, unplug power cord from receptacle.

High and low temperature limiting thermostats are preset at the factory and should perform satisfactorily for the life of the HEMOTHERM unit. If operation is judged faulty, the thermostat(s) must be replaced and recalibrated. Inaccurate or improper calibration can conceivably cause patient harm. The procedure for

recalibration, ,.is discussed in this manual, should be followed with extreme care.

The repair, calibration and servicing of the HEMOTHERM unit requires no special tools. However, no attempt should be made to perform any of the repair, calibration, or service procedures outlined in this manual unless the proper skills and knowledge are possessed.

Exercise extreme caution if this equipment is used on electrically susceptible patients (probe, catheter or electrodes directly connected to the heart). Always test for current leakage before use. Additional warnings are expressed at appropriate points in the manual.

1.7 Equipment Description and Specifications

Equipment descriptions and specifications for the HEMOTHERM Cooler/ Heater System are included in Tables 1-1

and 1-2. They are subject to change without notice. I

I I I I I

I I



Table 1-1 HEMGTHERiV^^System Equipment and Accessories

I Cat. No. HEMOTHERM Equipment 400 HEMOTHERM Dual Reser

voir Cooler/Heater EPP Explosion-proof plug

Cat. No. Long-Life, Field Repairable Blankets (Herculite® Staph-chek)

155 O.R. Table Size (22" x 60") 174 Pediatric Size (23" X 30") 185 8' Blanket Extension Hose

with Couplings (Extra Length Hose Available)

Cat. No. Thermistor Probes (Yellow Springs Instrument Co.)

401 YSI (Esophageal or Rectal) 402 YSI (Infant - Esophageal or

Rectal) 408 YSI (BANJO - Surface Tem

perature) 409 YSI (Attachable Surface

Temperature - Tape on Skin) 409PH Probe Holder for YSI 409 440 Probe Extension Cord -15'

Length

Cat. No. PLASTIPAD Light-Duty

P

355

374

165 164 186

168

Cat. No.

266 286

Cat No.

Molded Plastic (Polyurethane) O.R. Table Size (22" x 60") Pediatric Size (22" x 30") 8' Blanket Extension Hose With Couplings (Extra Length Hose Available) PLASTIPAD Patch Kit

MAXI-THERM'"Single Patient Use Hyper-Hypothermia Blankets Contents: 20 Blankets per Case (4 Shelf Cartons of 5 Each) O.R. Table Size (26" x 60") 9' connecting hose

DISPOSA COVERS™- (Dis-posable Covers for Hyper-Hypothermia Blankets Contents: 100 Covers per Case (4 Shelf Cartons of 25 Each) O.R. Table Size - Bag Style (for Cat. no. 155 & 165 Blankets) Pediatric Size - Bag Style (for Cat. no. 174 - Long Life and Cat. no. 164 Plastic Blankets)



Table 1-2 HEMOTHERfvflSystem Equipment Specifications

FEATURES CSZ HEMOTHERM

MODEL 400

PHYSICAL

Dimensions Floor Space Consumed Weight Cabinet Construction Warm Air Flow

22"W X 22"D x 32"H 484 sq. in. 198 lbs. 16 ga. steel . Bottom (downward)

CONTROL SYSTEM Fluid Temp.

Control Range Fluid Temp.

Control Accuracy Temp. Setting

(Fluid)

C\ I ^

3°C. to 42°C. f

+.5°C. r \

1°C.

COOLING SYSTEM Compressor Compressor Mfr. Fluid cooling Range

1/2 HP Copeland 32°C. to 3°C.

HEATING SYSTEM Power Rating

Fluid Heating Range

300 Watts Lo Heat -1500 Watts Hi Heat

25°C. to 42°C.

ELECTRICAL Electrical

Characteristics (STD.)

(OPT.)

Outlet Required

Power Cord

Current Leakage Circuit Breaker

115VAC, 60 Hz., 15.5 amps

220VAC, 50/60 Hz., 8 amps

20 amps, AC grounded(115V)

14 AWG, 3-wire grounded, hospital-grade plug

Under 100 microamps External Resettable

FEATURES CSZ HEMOTHERM

MODEL 400

SAFETY

Hi Limit Thermostat Low Limit Thermostat Thermostats

Adjustable Operating Instructions on Unit

43°C. 2°C.

Yes

Yes

SERVICEABILITY Easy to Maintain Easy to Field-

Service Special Tools

Required Warranty Period

Return to Factory for Service

Yes

Yes

No 1 yr. parts (Compressor 4 yrs.

additional prorated) M

No fl ^

CIRCULATING SYSTEM Reservoir Capacity

Reservoir Fluid

Reservoir Opening Reservoir

Construction Flow Rate

Maximum Pressure

Quick Disconnect Fittings

Cool - 6-1/2 qts. Heat - 7 qts. Distilled or Tap Water Large, Easy-to-Fill

Stainless Steel 19 Liters/Minute through self-sealing Hansen Fittings 23 Liters/Minute with

flow through Hansen Fittings

15 psi - Heat

•? m ^

I

Exchanger Connections^ 10 psi - Blanket

Connections

1 Set 1/2" Hansens for Heat Exchanger,

1

1 1 Set 1/8" Hansens

for Blanket, 1 Set 1/4" Hansens

for draining (on unit); 1 additional set 1/2" Hansens included for tubing

I I



I

I I I I I I I p I I I i I I

1.8 Clinical Applications

The HEMOTHERM™ Dual Reservoir Cooler/Heater was designed specifically for use in the extracorporeal circuit. The unit is a self-contained temperature control device designed to deliver chilled or heated water to the blood heat exchanger in the cardiopulmonary bypass circuit.

The HEMOTHERM Cooler/Heater will develop and maintain temperatures in adults from 13 C. to 39°C.

There are many variables that affect the heating or cooling of the patient in the extracorporeal circuit. These include the weight.

blood flow, gas flow, oxygenator/ heat exchanger type. The HEMOTHERM Cooler/Heater has been designed to provide high water flow rates at low pressure for safe and highly efficient operation with all currently available heat exchangers.

The HEMOTHERM Cooler/Heater can maintain normal body temperature (normothermia), particularly during lengthy surgical procedures or, where the ambient (room) temperature is set low. This can be done with the use of a Hyper-Hypothermia blanket underneath the patient.

I I



2.1 Initial Set-Up

I

Steps 1-11 should be followed the first time the HEMOTHERM™Unit is set-up. For subsequent operation, refer to General Operation Instructions, Paragraph 1.5.

1. Collect proper equipment and supplies.

A. HEMOTHERM unit. B. Hyper-Hypothermia Blanket. C. DISPOSA-COVER disposable

blanket cover.

D. 17 quarts of distilled or tap water.(The cold reservoir holds 6-1/2 quarts, the hot reservoir holds 7 qts., the blanket holds 2 qts., and approximately 1.5 qts. will be required to fill the connecting lines and the heat exchanger.) No alcohol is required.

E. Bacteriostatic or bacteriocidal agent, if desired. (We suggest .25% Phenol or Ethylene Glycol; see Paragraph 2.3 for proper mixture.)

2. Lift reservoir lid and remove individual reservoir covers. Fill cold reservoir with 6-1/2 qts. of distilled or tap water, and the hot reservoir with 7 qts. of distilled or tap water. The level should be approximately 1" from the top of each reservoir.

3. Add bacteriocidal agent, if desired (see Paragraph 2.3).

4. Make sure power switch and pump switch are in the "OFF" position.

5. Insert plug into properly grounded, securely mounted receptacle. Grounding reliability can only be

10.

11.

achieved when connected to an equivalent hospital grade receptacle. Do not bypass the third, or grounding plug. An electrical hazard may result if it is bypassed, removed or otherwise rendered useless. If an extension cord is used, it also must be 3-wire and of at least 14 gauge.

Place HEMOTHERM unit next to or near heat exchanger, or in another convenient location.

Lay the Hyper-Hypothermia blanket on the O.R. table (end zippers down if using the Herculite Staph-Chek Blanket), with hose at tachments as close to where the HEMOTHERM unit will be placed during operation. Cover the blanket with a CSZ DISPOSA-COVER, sheet, or bath blanket.

Attach heat exchanger and the blanket (if desired) connecting lines to the HEMOTHERM unit (see Paragraph 2.2).

Read operating instructions on the control panel before starting the unit. Familiarize yourself with the name and location of all features and controls shown.

Fill the heat exchanger (and blanket by activating the power switch, waiting 15 seconds, and then act i vating the pump switch. Add more distilled or tap water to the reservoir of mode selected when filling.

Proceed to Operating Instructions -Heat or Cool Mode (see Paragraph 1.5).

I I I I I I J

•I I I I I I I

10 I I



I 2.2 Connection Procedure

I I I I I I I ( »

I I I I I I

I I

Take the set of 1/2" Hansen self-sealing fittings and attach them to two (2), 1/2" LD. plastic tubes (long enough to reach from the HEMOTHERM™ unit to the Heat Exchanger). The shorter the length of tubing, the greater the flow rate. The female fitting should be attached to the tube leading to the Heat Exchanger's water inlet, and the male fitting should be attached to the Heat Exchanger's water outlet.

After attaching the tubes to the heat exchanger, attach the 1/2"

Hansen self-sealing fittings to the matched fittings on the lower right side of the HEMOTHERM unit (see Figure 5.1).

Attach the 1/8" Hansen self-sealing fittings leading from the Hyper-Hypothermia blanket to the matching set of 1/8" Hansen self-sealing fittings on the lower right hand side of the HEMOTHERM unit.

The air in the lines will be bled out as soon as the pump switch is activated. Check the water level of the reservoirs after filling connecting water lines.

2.3 Suggestions for Protecting the Reservoir from Bacteria

As a general rule, if sterile distilled water is used and changed monthly, there should be no problem with bacteria forming in the reservoir or blanket. If your hospital's procedure requires the use of a bacteriostatic or bacteriocidal agent (you may then choose either sterile or non-sterile distilled water), we would suggest one of the following, in the order of our preference:

.25% Phenol

Ethylene Glycol

(2Ice per 7 qt. hot reservoir of distilled or tap water; 20cc per 6-1/2 qt. cold reservoir of distilled or tap water.)

(fill the hot reservoir with a mixture of 1.4 qts. Ethylene Glycol, plus 5.6 qts. of distilled or tap water;

fill the cold reservoir with a mixture of 1.3 qts. Ethylene Glycol, plus 5.2 qts. of distilled or tap water.)

Other preferred agents are acceptable, provided they have a non-acid pH (Le., 750cc. Hydrogen Peroxide per 2-1/2 gallons of sterile distilled water).

WARNINGS & PRECAUTIONS Both Phenol and Ethylene Glycol are toxic if ingested, and extreme care should be exercised with use around children.

11



I 2.4 Built-in Safety Precautions

1. A Low Limit Thermostat will automatically shut off the compressor and the compressor indicator light at 2°C.. However, the circulating pump continues to operate. In the unlikely event that the thermostat should malfunction, the water will freeze, provided no antifreeze solution has been added to prevent it. This will also shut off the circulating system.

2. A High Limit Thermostat will automatically shut off the heater and "Heat" indicator lights should the water temperature reach 43 C. Again, the circulating pump will continue to operate.

If this happens, a high temperature warning light on the front of the panel will also illuminate. Then, the unit should be returned to the maintenance or engineering department to inspect the high temperature safety system.

Circuit Breaker - The HEMOTHERM™ unit (right side) is equipped with an over-current protection circuit breaker to protect the unit and the hospital wiring system against possible overload. If the circuit breaker trips, the red button will pop out. To reset, simply push it back in. If it trips again, return it to maintenance department.

I I I I I I I

^

I I I I I I

12

I I



•

.DEPARTMENT OF.-HEALTH AND HUMAN SJERVICES " ' " " P U B L I C HEALTH SERVICE "

FOOD A.ND DRUG ,ADM.I_NlSTF^TION " . . SILVER SPRING. MARYLAND Zp's IO

July 13, 198i

kef: K8I17 42 HEMOTHERM, Model ' OO " •

Cincinnati Sub-Zero Products, Inc Attn: Leonard Berke 2612 Gilbert Avenue Cincinnati, Ohio 45206

We. a're ho.lding your above-referenced 510(k) submission f o r _ _ j . ' y •30 days pending receipt of additional information thatvas'.. requested by this Agency. 'This inforrriation should be •. submitted in duplicate"to; " . ' ' ' ' . •

Food and Drug Administration Bureau of Medical Devices ,. < Document Control Center (HFK-20) . '""

•;• " 8757 Georgia Avenue Silver Spring., HD 20910

If after 30 days the requested information 1s not received, your submission will be deleted from our system and returned to you. If you then wish to resubmit this 510(k) notification, a new number will be assigned and acknowledged upon receipt, __, and the 90-day time period will begin again.

Sincerely yo

mne C. McDowell ifting Chief

Document Control Center _ Bureau of Medical Devices

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From R e v i e w e r ( s ) . - 'Name Cs)"- '

Subject 510 (K) N o t i f i c a t i o n ••

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It is my recommendation that the subject 510(K) Notification;

(A) Is substantially equivalent to marketed devices.

(.B) Reguires premarket approval. NOT substantially ' ' equivalent to marketed devices.

y (C) • Requires .more data. (D) is an incomplete submission, (See Submission Sheet)

Additional Coraments: Class Code w/ Panel:

REVIEW.":" BRANCH CHIEF DATE

FINAL REVIEW; DIVISION DIRECTOR DATE

OPTIONAL REVIEW: ASSOC. DIRECTOR FOR DEVICE EVAL. DATE



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FORM FD 2034 (6/76)



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CSZ cinnati Sub-Zero

REC FDA/ . .' DP

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DOCUMl;'' • : . inOL /y*-.^-'

March 10, 198]

5f7Tn777>x'r/ 7" "CinfeiMjJiti Sub-Zero Prodilicts, Inc.

t> ?6,12 ^ y n Avenue -^^ CincinnafMpbio 45206 • i5\m>51-A8l|

N # ^ Qab^ SuWgro, Cincinnati

Mr. Lee C. Matthews, Chief Device Registration and Listing Branch, KFK 124 Bureau of Medical Devices DEPARTMENT OF HEALTE AND HUMAN SERVICES Public Health Service - FDA 8757 Georgia Avenue Silver Springs, MD 20910 ppmmm 7.H

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Dear Mr. Matthews,

This is a follow-up to our earlier telephone and letter communications with you relative to the "510Ck) Notification".

We are interested in including in our marketing efforts, a divice listed as the "HEMOTHERM, model 400". This is not, in fact, a new device but rather a variation of the model 200 HL BLANKETROl^ Cooler/Heater that has been on the market for over ten years (brochure covering the 200 HL, is attached).

The model 400 HEMOTHERM is designed for use in the same hospital area, by the same medical personnel and for the same applications and procedures. The only significant difference is that the model 400 will incorporate a dual reservoir system rather than a single reservoir, and a digital control and display system rather than an analogical control and display system.

In light of the fact that the HEMOTHERM is substantially the equivalent of the earlier model 200 HL BLANKETROL Cooler/Heater, we doubt that a "510 (k) Notification" is necessary. However, because we do want to comply with all requirements, we are sending this letter of notification and will appreciate your advising us on the matter.

We will also appreciate your supplying us with Form FD 2892 so that it can be completed and filed to assure our proper device listing.

Yours very truly,

C'lNCimSTl SUB-ZERO PRODUCTS, INC.

LB ab

jeonard Berke Vice President

Engineers and ivlanufacturers of Temperature and Environmental Control Equipment for Industry and Medicine



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f Ml m; (Cat No. 200HL)

The BLANKETROL HL delivers precisely controlled distilled water to a blood heat exchanger (disposable or reuseable) used with a heart/lung pump, at high flow rates and under relatively low pressure.

The BLANKETROL HL cools with a quiet, efficient compressor. No more ice. No more mess. No more need to introduce non-sterile material into the OR. And, the BLANKETROL HL utilizes a 1500 Watt heater for rapid rewarming.

The BLANKETROL HL is compact, simple to operate, and safe. It costs less, does more, and lasts longer. This versatile cooler/heater can be connected simultaneously to a heat exchanger and to a hyper-hypothermia blanket, or separately to either.

Compare the advantages of the BLANKETROL HL Cooler/Heater. • No ice, no mess. The BLANKETROL HL has a quiet, efficient % hp compressor. It's a 2 in 1 unit that cools better than wall water and similar to ice. The heating capability is equal to wall water*. You'll never have to haul non-sterile ice into the sterile environment of the OR. The BLANKETROL HL uses distilled water only, antd it is recycled. No five gallons per minute down the drain.

0 It's so simple to operate. Set the desired water temperature and flip the "on-off" switch. S Temperature control is precise. You can control the temperature of the water within ± ,5°F. between 3°C. and 42°C. (SB^F. and 108°F.) the year 'round. Of course, this range may be increased, upon physician's order, if so desired.

H Raise or lower water temperature quickly. Cools at approximately 5°F. per minute, warms at approximately 3.5°F. per minute. • High flow rates. Delivers approximately 20 liters per minute of cooled or heated water to a disposable or stainless steel heat exchanger.

B Cuts water costs. Distilled water is recirculated through the system. No money down the drain. • Dual function. Use with both a heat exchanger and hyper-hypothermia blanl<et. Multiple sets of quick-disconnect fittings do iL • It's safe. Compressor or heater automatically shuts off when temperature reaches the low (3°C.) or high (42°C.) factory preset limits. There's even a back-up high limit thermostat (45°C.) and a safety high temperature wa."---g light,

• It's field serv.ceable. The BLANKETROL HL stays in your hospital where you can use i t . . . no need to return to our factory. Most repairs can be made on-site without special tools.

• Maximizes cost containment. The BLANKETROL HL costs less to purchase, less to maintain. Use it also as a standard hyper-hypothermia unit for more return on your investment. Ask us for a cost comparison. We can show you, item for item, how the BLANKETROL HL gives superior service, longer life, and more versatility at less cost.

Get complete information including the cost containment story today. Call your BLANKETROL dealer or write our main office. 'Page, Paul A., B.S., C.C.P., P.A.: "Evaluation of a High Efficiency Heating-Cooling System for Hypotfiermic Open Heart Surgery", AmSECT Proceedings, 1976, Reprint available upon request.

^ '



BE.ANKSTROL^ HL SPECIFICATIONS PHYSICAL Dimensions Floor Space

Consumed Weight Cabinet Construction

Warm Air Flow

CONTROL SYSTEM Fluid Temp.

Control Range

30"Hx23"Wx16"D

368 sq. in. 190 lbs. 14 ga. epoxy finished

steel Side (Downward)

3°C. to 42°C. (38°F. to 108°F.;

±.5°F. 1°F. increments

Fluid Temp. Control Accuracy

Temp. Setting (Fluid)

COOLING SYSTEM Compressor % HP Compressor

Manufacturer Hupp Fluid Cooling Rate

(Unrestricted) 5°F./min. HEATING SYSTEM Power Rating 1500 Watts Fluid Heating Rate

(Unrestricted) 3.5°F./min.

ELECTRICAL Electrical Charac

teristics (Std.)

(Opt.)

Outlet Required Power Cord

Current Leakage Circuit Breaker

CIRCULATING SYSTEM

115VAC, 60H2., 16 amps,

220VAC, 60Hz., 8 amps.

20 amps., AC grounded 14 AWG, 3-wire

grounded, hospital grade, low ;.ta leakage

under 100;ja external resettable

Reservoir Capacity Reservoir Fluid Reservoir Opening Reservoir Construction Flow Rate Maximum Pressure

Blanket Control Capability

Quick Disconnect Fittings

Error-Proof Fittings (Male/Female)

21/2 gal. Distilled Water Large, Easy-to-Fill Stainless Steel 20 liters/min. 12 psi (completely

restricted)

Yes

Yes (1 set Vz" Hansen, 3 sets VB" Hansen on cooler/heater; 1 additional set Vz" Hansen included with unit)

Yes

SAFETY Primary & Secondary

High Limit Thermostats

Low Limit Thermostat Thermostats Adjustable Safety Hi-Temp

Warning Light Operating Instructions

on Unit

SERVICEABILITY Easy to Maintain Easy to Field-Service Special Tools Required Warranty Period

Return to Factory for Service

42°C. & 45°C. (108°F. &112°F. ±1°F,)

3°C, (38°F. ±1°F,) Yes

45°C, (112°F. ±1°F.)

Yes

Yes Yes No 1 yr. parts

(Compressor 4 yrs, additional prorated)

No

Indications The BLANKETROL 200 HL Cooler/Heater is indicated for delivery of precisely controlled distilled water to a blood tneat exchanger (disposable or reuseable) used with a heart/lung pump. It may also be used in conjunction with a hyper-hypothermla blanket. Contraindications Any use of this device other than for the above indications is at the risk of the user. Warnings & Precautions Do not operate in or near areas where explosive gases are in use or have been used. Do not use unattended. Constant monitoring of water and patient temperature by trained personnel is essential. Ivlake certain properly grounded receptacle is used and that unit is disconnected before inspection, maintenance, or service. Federal law restricts this device to sale and use by or on order of a physician.

OSZ Cincinnati Sub-Zero 2612 Gilbert Avenue Cincinnati, Ohio <)5206 (513) 751-8810

279

