Resuscitaire Birthing Room Warmer

Page 1

OPERATING PRECAUTIONS

GENERAL PRECAUTIONS

.

Federal Law restricts this device to sale by or on order of a physician.

.

Infant radiant warmers should be used only by properly trained personnel as directed by an appropriately

qualified physician aware of currently known hazards and benefits.

.

The functional checkout procedure should be performed before each use and after disassembly for

cleaning, servicing or maintenance. Refer to qualified service personnel if the unit does not perform as

specified.

.

The Cart/Bassinet End and Side panels cannot be used for pushing or pulling the Cart/Bassinet and or

Warmer.

.

Do not leave the infant unattended in the Cart/Bassinet when the side panels orthefront panel arefolded

down.

.

To avoid overheating or underheating, skin temperature must be continuously monitored and controlled

either manually or automatically. Rectal temperature should never be used to control skin temperature.

.

To avoid overheating or underheating when operating in manual mode, observe the infant constantly and

monitor the temperature using the temperature probe supplied with the equipment or another electronic

thermometer.

.

The skin temperature sensing probe must be in direct contact with the skin to provide accurate monitoring of the infant’s skin temperature. Failure to maintain direct skin contact can result in overheating and

possible burning. Check infant’s condition at least every fifteen minutes for correct Sensor attachment,

reddened skin areas, and proper skin temperature.

.

The skin temperature sensing probe should be placed at least 1.5 inches from any transcutaneous monitor (TcPOz or TcPCOz) probe to prevent false temperature indications. The skin temperature probe

should not be placed on an area previously used by a TcPOz or TcPC02 probe.

.

To avoid overheating the skin, the location of the skin temperature probe must be such that the skin

around the Sensor is in direct line with the radiation from the warmer. Do not place anything between the

radiant warmer and the infant that will interfere with the radiation from the warmer.

.

Radiant warming increases insensible water loss. Appropriate measures to maintain proper fluid balance should be considered.

.

For effective heating, make sure the Warmer Module is positioned on the center axis and locked with its

detent.

.

This Warmer is intended for use with the Cart/Bassinet. If the Warmer is used to warm the mother immediately after delivery, all warnings and instructions should be followed with particular regard to the

heater-to-mattress distance and skin probe location. Avoid placement of objects near the mother which

can absorb heat and become hot to the touch.

.

Compressed gas cylinders, such as oxygen cylinders, can become hazardous projectiles if the gas is

released rapidly due to damage or other causes. Cylinders must be securely fastened.

.

To avoid overheating the Warmer, do not place objects (equipment, blankets, clothing or sterile packs) on

top of the Warmer.

COPYRIGHT@3 1998, HILL-ROM AIR-SHIELDS, INC.

Page 2

OPERATING PRECAUTIONS (Continued)

l

Avoid placement of objects between the infant and the Warmer Module that can block heat transfer or

absorb heat. These objects may be heated directly by the heater and can cause skin burns.

a

Temperature uniformity (per IEC 601-2-21) across the mattress surface may not be maintained when

the Bassinet is tilted in the 5- and 1 O-degree positions.

l

During calibration, inspect the secondary reflector directly under the warmer heater element for particles.

If particles are present, replace the heater element. The life expectancy of the heater element is 1000

hours of operation.

0

Evidence that the safety certification of the ACCESSORY has been performed in accordance with the

appropriate IEC 601-l and/or IEC 601-l-l harmonized national standard.

RESUSCITATION PRECAUTIONS

A one-way valve is installed at the Patient Outlet connection. This valve opens when pressure in the

hose delivering gas to the patient falls below -4 cm H20. Its purpose is to allow patient inspiration in the

unlikely event of failure of the gas supply.

A humidifier, when used, must be placed between the Patient Outlet connection and the patient circuit.

DO NOT PLACE A HUMIDIFIER IN THE SUPPLY LINE.

Humidifier must have low series flow resistance and not be placed between exhalation valve and patient

airway.

Gas going to the patient should not be super-saturated as evidenced by excessive condensation in the

tubing. Condensation droplets on the inner walls of the tubing are normal.

Periodic blood gas measurements should be made to ensure proper levels of ventilation.

Always confirm the airway pressure relief valve setting before patient use.

Confirm that the oxygen/air blender control of the Blended Gas Supply Module is correctly set prior to

use.

Confirm that the patient circuit contains all the parts needed prior to use.

Ensure that the patient breathing circuit connections are secure and free of obstructions.

The Aux Outlet circuit does not provide adjustable pressure limiting.

Auxiliary Gas Supply Pressure is internally limited to 160 cm HzO. Always use a patient resuscitation

circuit that includes appropriate pressure relief.

Always monitor Airway Pressure and/or provide appropriate pressure relief during infant resuscitation.

Confirm that the oxygen supply is turned off and that the equipment is disconnected from the oxygen

supply when performing cleaning and maintenance procedures; a fire and explosion hazard exists when

performing cleaning and/or maintenance procedures in an oxygen-enriched environment.

Gas supplies (02 and Air) should always be clean and dry. Water/Trap Filters should be used in the supply lines if necessary.

All hoses should be securely fastened to fittings. Hand-tighten to avoid damage to fittings.

Gas supplies should be maintained at 40 to 75 psi.

Flow restrictions (e.g., flowmeter, valve, etc.) must not be placed in the supply line.

If a compressor is used as the air source, steps should be taken to filter and dehumidify the room air

before introducing it into the Gas Supply Module.

_ ii _

Page 3

OPERATING PRECAUTIONS (Continued)

ELECTRICAL PRECAUTIONS

a

An electrical shock hazard exists within the Warmer Module and Controller. Any substitution of components within the Controller or Warmer Module may impair the intrinsic safety of the unit. Service should

be performed by qualified personnel.

0

Connect the power cord only to a properly grounded receptacle that is approved for hospital use and of

the correct voltage. DO NOT USE EXTENSION CORDS.

l

Use only with power cords supplied with the Warmer.

EXPLOSION PRECAUTIONS

l

Do not use in the presence of flammable anesthetics.

0

Confirm that the oxygen supply is turned off and that the equipment is disconnected from the oxygen

supply when performing cleaning and maintenance procedures; a fire and explosion hazard exists when

performing cleaning and/or maintenance procedures in an oxygen-enriched environment.

OXYGEN PRECAUTIONS

l

Improper use of supplemental oxygen may be associated with serious side effects including blindness,

brain damage, and death. The risks vary with each infant. The method, the concentration, and the duration of oxygen administration should be prescribed by the attending physician.

.

If it is necessary to administer oxygen in an emergency, the attending physician should be notified immediately.

NOTE: See the current edition of “Guidelines for Perinatal Care”of the American Academy of Pediatrics/The

American College of Obstetricians and Gynecologists.

.

The oxygen concentration inspired by an infant does not predictably determine the partial pressure of

oxygen (PO,) in the blood. When deemed advisable by the attending physician, blood PO2 should be

measured by accepted clinical techniques.

.

Oxygen flow rates cannot be used as an accurate indication of oxygen concentrations. Oxygen concentrations should be measured with acalibrated oxygen analyzer at intervals directed by the attending physician.

.

Keep matches and all other sources of ignition out of the room in which the Warmer is located and keep

spark-producing equipment or any sources of ignition out of the Bassinet. Wood, textiles, oils, and other

combustibles are easily ignited and burn with great intensity in air enriched with oxygen.

.

Although oxygen compatible materials are used in the oxygen delivery system, special care must be taken when high pressure oxygen such as found in a medical oxygen cylinder is used. Violent ignition of oil,

grease, greasy substances, small particles of dust, dirt or other particulate contaminants (even small

particles of metal), can occur in the presence of high pressure oxygen if their ignition temperature is

reached. An instantaneous increase in temperature can occur due to friction, particle acceleration, or

adiabatic compression, if the oxygen cylinder valve is opened too rapidly. SERIOUS INJURY MAY RESULT! Always observe the following precautions:

-

Oil, grease, greasy substances, dust, dirt and other particulate contaminants must be kept away

from oxygen regulators, cylinder valves, tubing and all other oxygen equipment.

- III -

Page 4

OPERATING PRECAUTIONS (Continued)

-

Always open oxygen cylinder shut-off valves very slowly and carefully.

-

On high pressure oxygen cylinders use only pressure regulators or reducing valves approved for

oxygen service. Do not use oxygen pressure regulators or reducing valves for air or gases other

than oxygen as they may be hazardous. Operate such devices in strict accordance with the

manufacturer’s recommendations.

-

When new or replacement oxygen cylinders are to be installed, they should have their outlet ports

cleared by cracking the cylinder valve momentarily before attachment to the equipment.

LOW FLOW MICROBLENDER WARNINGS

l

If either the air or oxygen gas source pressure is reduced or increased creating a pressure

differential of 30 psi, the microblender alarm will sound. This condition significantly alters the

FiO2 and flow output from the microblender.

Always operate the low flow microblender with clean/dry medical grade gases.

.

Air inlet water filters are recommended for use with the low flow microblender.

.

The level of oxygen and the partial pressure of oxygen within the patient’s blood

should be monitored.

l

- iv -

(Pa02)

Page 5

TABLE OF DEFINITIONS AND SYMBOLS

NOTE, IMPORTANT, PRECAUTION, CAUTION, AND WARNING

NOTE: A Note is inserted in text to point outprocedures or conditions which may otherwise be misinterpreted

or overlooked. A Note may also be used to clarify apparent/y contradictory or confusing situations.

IMPORTANT

Similar to a Note but used when greater emphasis is required.

PRECAUTION: A Precaution is supplementalinformation

equipment.

CAUTION:

to assist the user in the safe and effective use of the

A Caution is inserted in text to call attention to a procedure which, if not followed exactly,

can lead to damage or destruction of the equipment.

WARNING: A Warning is inserted in text to call attention to dangerous or hazardous conditions

inherent to the operation, cleaning, and maintenance of the equipment which may result In personal injury or death of the operator or patient.

SYMBOLS

/

o-

\

Attention: consult

accompanying documents.

-

Examination Light

08

’ I ’

Type B equipment with an F-type

isolated (floating) applied part.

Examination Light Switch

A

Mode Control Key

8

Danger! High Voltage!

Temperature Override Mode

Key

Keypad Lock Key

Disposable Suction Bottle

00

Reusable Suction Bottle

I

Set Temperature Keys

Power On/Off Switch

Celsius/Fahrenheit Selection

Key

Patient

Heater Element

Silence/Reset Key

Suction Line Filter

Procedural Silence Indicator

w@

Load Symbol

-V-

Apgar Timer Keys

Page 7

TABLE OF CONTENTS (continued)

SECTION

5.4.4 METAL SURFACES ...............................................................

5.4.5 WOODEN SURFACES ............................................................

5.4.6 SKIN TEMPERATURE PROBE (REUSABLE) .........................................

5.5 STERILIZATION .......................................................................

5.6 REASSEMBLY AFTER CLEANING ......................................................

5.7 CALIBRATION .........................................................................

5.8 TROUBLESHOOTING ..................................................................

6 PARTS LIST .......................................................................

6.1 GENERAL .............................................................................

-vii-

PAGE

34

34

35

35

35

35

35

37

37

Page 8

RESUSCITAIREB BIRTHING ROOM WARMER

SECTION 1

GENERAL INFORMATION

please contact your Hill-Rom Air-Shields’ representative for further information.

1 .l INTRODUCTION

This manual provides instructions for installation,

use, operator maintenance and troubleshooting of

the equipment. Hill-Rom Air-Shields cannot be responsible for the performance of the equipment if

the user does not operate the equipment in accordance with the instructions, fails to follow the maintenance recommendations in Section 5 of this

manual or effects any repairs with unauthorized

components. Calibration and repair should be performed only by qualified service personnel. Service

manuals are available from Hill-Rom Air-Shields.

1.2 DESCRIPTION

The ResuscitaireB Birthing Room Warmer is designed specifically for birthing room use. The Resuscitaire8 Birthing Room Warmer consists of a

detachable Cart/Bassinet, Warmer, and a Controller module which provides heat control, monitoring

of skin temperature and Apgar timing. The Resuscitaire8 Birthing Room Warmer also includes an

optional resuscitation package with suction and

oxygen delivery. Other options include a reserve

gas supply and blender.

This manual should be read, thoroughly understood, and be readily accessible to all personnel

who will be working with the equipment. The manual

should be stored with the equipment when not in

use. If there is anything you do not understand,

1.3 SPECIFICATIONS

Specifications for the

ResoscitaireB Birthing

Room Warmer are provided in Table 1 .l . All specifications are subject to change without notice.

-l-

Page 9

RESUSCITAIREGI BIRTHING ROOM WARMER

TABLE 1.1 SPECIFICATIONS

POWER REQUIREMENTS ...........................................

12OV, 60 Hz, 750W

OVERLOAD PROTECTION ..................................... Dual 12A Circuit Breakers

CHASSIS LEAKAGE CURRENT

....................................... Less than 300 uA

EXAMINATION LIGHT. .............................. >lOO Foot Candles (0.12 lumens/cm:z)

ALARMS

High Temperature

................................ Activates if Skin Temperature Probe is

attached and the skin temperature

sensor reaches 39.0 “C. Resets at 38.5 “(3.

Check Patient ................................ Activates in Manual Mode after 10 minutes.

Remains on with audible alarm every

30 seconds for 5 minutes;

totalling 15 minutes. Then the heater is turned Off.

Apgar Timer ............................................Activates at the l-, 5-and lominute Apgar Time intervals.

Power Fail ................................................... Activates when there is a

loss of power.

Probe.. .......................................

Activates if Skin Temperature Probe fails

(open or short).

SystemFail ..........................................

Indicates system failure; refer unit

to service immediately.

BabyTemp ..............................................

Activates if Baby Temperature

fluctuates 1 “C above or below set poirit.

Electrical Module Audio Alarms ....................... Tone Frequency: 1.2 KHz maximum

Three-stage sound level: 15 seconcls

low, 15 seconds medium, then high.

Blender Module Pneumatic Audio Alarm ..................................Vibrating Reed.

DISPLAYS

Skin Temperature Display

Accuracy.. .................................

f 0.2 “C for 31 “C to 37 “C (88 “F to 98.6 “F)

Resolution .............................................................0.1 “C (0.5 “F)

Apgar Timer Display

Range ...............................................

Resolution .................................................................

Accuracy .............................................................

MANUAL HEAT CONTROL

0 to 59 minutes, 0 to 59 seconcls

lsecond

Of0.5second

..................................Adjustable in 10% increments

from zero to full power (100 %#)

DATA PORT .....................................................

2400 Bits/second fixed

Baud Rate. RS232C Compatible

DIMENSIONS AND WEIGHT-FREE STANDING WARMER

Height ...........................................................

74 inches (188 cm)

Width (side to side) ................................................

28 inches (102 cm)

Depth (front to back) .................................................40 inches (89 cm)

Weight (without tanks) ................................................. 170 Ibs (77 kg)

Warmer Head Rotation (right and left) .......................................

90 Degrees

-2-

Page 10

RESUSCITAIREGO BIRTHING ROOM WARMER

TABLE 1 .I SPECIFICATIONS (Cont.)

DIMENSIONS AND WEIGHT - Cart/Bassinet

38.5 inches (98 cm)

Height to Mattress ................................................

Width (to outside of bumper) ......................................... 24 inches (61 cm)

Length (to outside bumper) .......................................... 31 inches (79 cm)

Weight ........................................................... c 160 Ibs (c73 Kg)

5 and 10 degrees Reverse Trendelenburg.

MattressTilt .................................

Infant’s head should be toward front of warmer.

TOTAL SYSTEM DIMENSIONS AND WEIGHT

..74inches(188cm)

Height .........................................................

28inches (71 cm)

Width .............................................................

48inches(122cm)

Length ..........................................................

..c320Ibs(c152Kg )

Weight ........................................................

ACCESSORY WEIGHT LIMITS

5 Ibs (2.2 Kg)

Infusion Pump/IV Pole ...................................................

Monitor Shelf .......................................................... 10 Ibs (4.5 Kg)

ENVIRONMENTAL

.................................. 18 “C to 30 “C ambfent

Operating Temperature Range

Storage Temperature Range ..................................- 20 “C to +45 “C ambient

Relative Humidity Operating Range .................. 5% RH to 95% RH, non-condensrng

RESUSCITATION

Wall Supply Pressure ...................................................

Cylinder Pressure .....................................................

Cylinder Diameter ............................................

40 to 75 psi

2900 psi max

4-5 inches( 1 O-l 2 cm)

Patient Gas Supply

0 to 50 cm Hz0 (4.9 kPa) + 10%

Airway Pressure Limiting Operator-Adjustable

.. . 60 cm Hz0 (5.9 kPa) 2 10%

Fixed Pressure Relief, Factory Set .....................................

Suction Circuit

0 to 150 mmHg (0 to 20 kPa)

Adjustable Suction Intensity ................................

Auxiliary Supply

0 to 15 LPM

Auxiliary Flow Range .....................................................

Auxiliary Pressure Limit .................................... 160 cm Hz0 (16 kPa) -c 10%

.

1.4 EQUIPMENT PROVIDED

.

.

Bassinet - The Bassinet provides maximum

visibility and access to the infant. The Bassinet tilts up in the rear to 5 and 10 degrees and

provides for X-ray Cassette tray (optional) insertion.

.

Warmer Module - The Warmer Module

houses a heating element and an Examination Light for special procedures.

-3-

Controller - The Controller provides prewarm, manual heat control, automatic skin

temperature servo-control and contains an

Apgar Timer, Skin Temperature monitor and

probe.

Resuscitation Module (optional) -The Resuscitation Module contains a suction circuit, a

patient oxygen delivery circuit with airway

pressure relief and an auxiliary oxygen delivery circuit.

Page 11

RESUSCITAIR~ BIRTHING ROOM WARMER

1.5 FACTORY INSTALLED OPTIONS

.

Resuscitation Module

.

Integrated Precision Blender

.

Gas Supply Module

1.6

FIELD INSTALLED ACCESSORIES

(Refer to Section 6 for Part Numbers)

.

X-ray Cassette Tray

.

Air Hose Assembly

.

Oxygen Hose Assembly

.

Monitor Shelf

-

02 Pipeline and Cylinder

.

I.V. Pole

-

Oz/Air Pipeline and Cylinder

.

Drawer Organizer

-4-

Page 12

RESUSCITAIREB BIRTHING ROOM WARMER

DRAWER

LOCK

PASS-THROUGH

DRAWER

CASTER LOCK

WARMER MODULE

CONTROLLER

MONITOR SHELF

/

3c.

iT TILT

MtwiANISM

\

BLENDED GAS

SUPPLY MODULE

RESUSCITATION

GAS SUPPLY MODULE

X-RAY TRAY 4

WALL 02/AIR

GAS HOSES

- GAS TANKS

(NOT SUPPLIED)

SUCTION BOTTLE

CAiTER LOCK

PASS-THROUGH DRAWER

FACTORY INSTALLED OPTIONS AND

FIELD INSTALLED ACCESSORIES

FIGURE 1 .I EQUIPMENT PROVIDED WITH

-5-

Page 13

RESUSCITAIREGQ BIRTHING ROOM WARMER

SECTION 2

INSTALLATION

2.1 UNPACKING

7.

SLOWLY LOWER THE WARMER (7) onto the

Upper Post. Tighten the upper screws and

install the remaining four 10 - 32 x 3/8 inch

screws (6).

8.

THREAD THE WARMER POWER CABLE

out through the Controller opening. Connect

the Power Cable (10) to connector J4 on the

Controller (3).

9.

REMOUNTTHE CONTROLLER on the Upper

Post.

10

MOUNT THE BACK COVER (1) on the Upper

Column using the six 8

- 32 x 3/4 painted

screws (5).

11.

MOUNT THE HANDLE (12) on the Post using

the two 10 - 32 x 2.6 inch Phillips Head

Screws, No. 10 Lock Washers and Spacers

The ResuscitaireB Birthing Room Warmer is

shipped in two cartons. One carton contains the following assemblies:

.

Upper Post Assembly

.

Lower Post Assembly

.

Warmer Module Assembly

.

Post Handle

.

Any user installed Accessories that were ordered

The other carton contains the Cart/Bassinet.

2.2

ASSEMBLY OF THE WARMER

FER TO FIGURE 2.1)

(RE-

When removing the equipment from the carton, use

care not to scratch or otherwise damage unprotected surfaces; remove all packing material.

(13 1 (14 1 (15 ).

12. CONNECT THE LINE CORD to the Power

Connector on the rear of the Controller (refer to

Figure 4.2).

NOTE: If a Monitor Shelf is to be installed on the

unit, refer to the instructions provided with

the Monitor Shelf and install the weights

provided with these accessories in the bottom of the Lower Post.

1.

REMOVE THE CONTROLLER (3)

Upper Post (2).

13. SECURE THE LINE CORD to the Back Cover

(1) using the Cable Clamp (8) and 8 - 32 x 3/8

screw (9).

from the

CAUTION: Securing the Line Cord to the Back

Panel is required to prevent removal

of the Controller chassis with the ac

power applied.

CAUTION: Two persons of sufficient strength

are required when performing Steps

3 through 6.

2.

REST THE UPPER POST (2)

Lower Post opening.

3.

CONNECT THE SUCTION HOSE (4) to the

Suction Hose (11). Release the joined Suction

Hoses from the Neat Clip inside the Lower Column.

14. INSTALL ANY ACCESSORIES that were ordered using the installation instructions provided with the accessory.

on top of the

4.

MOUNT THE UPPER POST (2) on the Lower

Post using four 10 - 32 x 3/8 inch screws (16)

provided.

5.

INSTALL TWO 10 - 32 X 3/8 INCH SCREWS

(6) IN THE UPPER HOLES OF THE UPPER

POST. Do not tighten the screws.

6.

RAISE THE WARMER (7) above the open end

of the Upper Post (2) and insert the Power

Cable (10) into the open end of the column.

2.3

1.

2.

-6

ASSEMBLY OF THE CART/BASSINET

Refer to Paragraph 5.6, Step 4, and install the

Rear and Side Panels. Raise the Front Panel

from its storage slot and lock it in place.

ENGAGE THE CART/BASSINET TO THE

WARMER by pushing the Cart/Bassinet

straight onto the Warmer until it latches. Pull on

the Cart/Bassinet to ensure that it is latched

properly.

To disengage the Cart/Bassinet from the

Warmer, push and hold the release switch

(Figure 4.14) and pull the Cart/Bassinet away

from the Warmer.

Page 14

RESUSCITAIREB BIRTHING ROOM WARMER

PARTS LIST

Screw, lo-32~3/8(QtylO) . ...99041 36

Screw, 10 - 32 x 2.6 (Qty 2) . . . . .99 045 30

Screw, 8 - 32 x 3/4 (Qty 6) . . . . .99 032 85

Screw, 8 -32 x 3/8 (Qty 1) . . . . . .99 031 38

No.iOLockWasher . . . . . . . . . . . . 9912416

Spacer (Qty 2) . . . . . . . . . . . . . . . . .99 124 61

..1772564

Cable Clamp

Post Handle . : : : : 1: : : : : : : : 1: : . .81 005 73

FIGURE 2.1 INSTALLATION

-7-

Page 15

RESUSCITAIREB BIRTHING ROOM WARMER

SECTION 3

FUNCTIONAL DESCRIPTION

3.1 GENERAL

This section provides a functional description of the

equipment.

3.2 FUNCTIONAL DESCRIPTION

3.2.1 WARMER MODULE

full power. After 10 minutes of operation in the Manual Mode, a Chk Patient Alarm occurs.

Failure to acknowledge the Check Patient Alarm by

pressing the Silence/Reset Key within the next 5

minutes will cause the heater to be shut down.

The Apgar Timer displays the elapsed time and

sounds an audible dual tone to alert the operator

that 1, 5, and 10 minutes have elapsed since the

timer was activated.

The Warmer is controlled by a Controller which provides Pre-Warm Mode, Manual Mode heater control, or Baby Mode (automatic skin temperature

control). An Examination Light provides added illumination of the mattress area. A Warmer Head Pivot

permits the Warmer to be pivoted to either side for

X-ray procedures. In addition, when the Warmer is

pivoted, it can be powered and provide heat.

When operated in the Baby Mode, the Controller

utilizes a Skin Temperature Probe, connected between the Controller input and the infant, to automatically adjust the heater output of the Warmer

Module to maintain a digitally displayed preset Set

Temperature.

3.2.2 CART/BASSINET

The Bassinet is designed to provide maximum function and utility to aid in the care of the newborn. It is

detachable so that the infant can be transported to

the NICU, the general nursery or another area of the

hospital. The side and front panels may be folded

down to permit maximum access to the infant. The

mattress may be tilted up in the rear at a 0, 5- or

lo-degree angle. Openings are provided on each

side of the Bassinet for the insertion of the optional

X-ray Cassette Tray.

3.2.3 CONTROLLER

The Keypad Lock Key, when pressed, renders the

Up/Down Arrows and Select Mode Keys inactive or

active.

Also included is a Procedural Silence Timer to block

out Baby Temp audible Alarms during routine procedures.

3.2.4 BLENDER MODULE (OPTIONAL)

The Blender Module provides blended oxygen from

21% to 100% to the Patient Outlet on the Resuscitation Module.

3.2.5 RESUSCITATION MODULE (OPTIONAL)

At power-up, the microprocessor within the Controller performs a series of diagnostic tests to confirm the proper operation of the system. During this

time, all displays and indicators are lighted (except

Power Fail) and an audible tone is sounded.

The Resuscitation Module contains pneumatic circuitry necessary for infant resuscitation. Controls

and displays for the module are located above and

to the rear of the Bassinet.

The Resuscitation Module consists of the following

components:

PreWhen powered up, the system initializes in

Warm Mode, the Controller will start the heater at

100% power and maintain that setting forthree minutes, reduce to 60% for 12 minutes and then reduce

the heater power to 30%.

.

When operating the Controller in the Manual Mode,

the operator can adjust the heater power from 0 to

-8-

Suction - The Suction Circuit (reusable or

disposable) is driven by a gas powered venturi

actuated vacuum generator which provides a

negative pressure for suctioning the patient’s

airway. The suction pressure is indicated on

the Suction Gauge (Figure 3.1). Suction pres-

Page 16

RESUSCITAIR~ BIRTHING ROOM WARMER

Switch. A fixed internal relief valve limits the

maximum suction level to 150 mmHg.

sure may be adjusted using the Suction Control or turned on and off using the On/Off

Extension Tube

Suction Catheter

Suction Catheter

I

I

‘Extension Tube

Disposable

Reusable

Note: Disposable bottle

has built-in filter

FIGURE 3.1 SUCTION FUNCTIONAL BLOCK DIAGRAM

-9-

Page 17

RESUSCITAIR~ BIRTHING ROOM WARMER

FIGURE 3.2 RESUSCITATION MODULE WITH PATIENT GAS SUPPLY AND

AUXILIARY FLOW

.

.

Patient Gas Supply -

The Patient Gas Supply Circuit may be used to

provide continuous gas flow to the patient. Controls

are provided for Airway Pressure Relief (maximum pressure) and Flow Rate (LPM) (circuit flow

delivering 100% oxygen or blended gas). The adjustable Airway Pressure Relief Control is always

operative.

A fixed internal safety relief valve is also provided

and is also always operable. This valve provides redundant maximum pressure relief at 50 + 10 cm

Hz0 and also allows the patient to inspire room air in

the event of gas supply failure.

Auxiliary Flow

The Aux Flow circuit supplies 100% oxygen

through the Aux Flow (LPM) Control to the Aux

Outlet Connector. It is intended for oxygen enrichment of a manual bag resuscitator, for supplemental

delivery to the patient, the mother, or a second neonate, i.e., twins. The Aux Flow (LPM) Control adjusts the flow rate from 0 to 15 Ipm. An internal preset relief valve limits the AUX Outlet pressure to

160 cm HzO.

.

Airway Pressure

The Airway Pressure Gauge displays airway pressure when connected to patient circuits via external

connection.

WARNING: Breathing room air through the

2-way relief valve requires extra effort. This

condition, if it occurs, should be rectified as

soon as possible.

.

Patient Breathing and Supply Circuits

The patient breathing circuit used in conjunction

with the Resuscitation Module is illustrated in Figure

3.3. In addition, a patient supply circuit for Manual

Bagging (Figure 3.4) may also be used.

-10

Page 18

RESUSCITAIREQXJ BIRTHING ROOM WARMER

l-CORRUGATED TUBING

5-EXHAUST PORT

2-EXHALATION VALVE HOUSING

6-PATIENT PORT

3-EXHALATION VALVE CAP

7-“T” FITTING

STEM

OF

ITEM

4

4-EXHALATION VALVE DIAPHRAGM

NOTE: EXHALATION VALVE DIAPHRAGM (ITEM 4)

MUST BE INSTALLED WITH DIAPHRAGM STEM

GAUGE

FIGURE 3.3 PATIENT BREATHING CIRCUIT FOR MANUAL VENTILATION

2-10 mm Corrugated Tubing

l-10/7.5 mm ID Adapter

3-15 mm/l0 mm Adapter

CONNECT BETWEEN PATIENT

OUTLET AND RESUSCITATION

FIGURE 3.4 PATIENT BREATHING CIRCUIT FOR MANUAL BAGGING

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Page 19

RESUSCITAIR~ BIRTHING ROOM WARMER

I

3.2.6

GAS SUPPLY MODULE (Optional)

The Gas Supply Module includes an On/Off Switch

which controls the pipeline and cylinder gas supply

to the Resuscitation Module. An oxygen cylinder

Pressure Gauge is provided if the Resuscitation option is included. Oxygen and Air Pressure Gauges

are provided on units equipped with the Blender

Module.

FIGURE 3.5 GAS SUPPLY MODULE

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Page 20

/?EsuscimmD BIRTHING ROOM WARMER

3.2.7 ALARMS

first at a low level, then at a medium level, then at a

high level. In addition, if the temperature is 0.2 “C

above the selected Set Temperature, the heater

will be turned off automatically. Press Silence/Reset to silence the alarm for 10 minutes.

HIGH TEMPERATURE. When the Skin Temperature Probe is attached to the infant and the skin temperature exceeds 39.0 “C, the heater is automatically turned off, the High Temp Indicator will flash

and the audible alarm will sound continuously.

Press the Silence/Reset Key to silence the alarm

for two minutes. After the alarm condition is corrected (a skin temperature of 38.5 “C or less), the

alarm will automatically reset. If the Skin Probe

should detect a temperature of 39.5 “C, a hardware

shutdown will occur and a System Fail Alarm will be

generated.

POWER FAIL. When ac power to the unit is interrupted while the Controller is on, the Power Fail Indicator will flash and the audible alarm will beep.

When power is restored to the unit, the alarm will

automatically reset and all the settings will be retained. The alarm may be silenced by turning off the

power switch.

CHECK PATIENT. When in the Manual Mode after

10 minutes of operation, the Chk Patient Indicator

will illuminate and the alarm will sound one time.

Thereafter, the Chk Patient Indicator will remain illuminated and the audible alarm will sound every 30

seconds for 5 minutes. If the alarm has not been acknowledged at the end of 5 minutes, the heater will

be shut down and a continuous ramping audible

alarm will sound. The Silence/Reset Key then must

be pressed to reactivate the heater.

PROBE. If the Skin Temperature Probe fails (shortcircuited or open) or if the Controller is in Baby Mode

and there is not a Skin Probe connected to the Controller, the Probe Indicator will flash and a ramping

audible alarm will sound. Afterthe alarm condition is

corrected (the Probe is replaced), the alarm will

automatically reset.

SYSTEM FAIL. If an internal malfunction is detected, the System Fail Indicator will flash and the

audible alarm will beep. In addition, an Error Code

(eRO0 to eR025) will be displayed in the BabyTemperature Display. This alarm is not resettable and

the unit should be referred to qualified service personnel. A prolonged brown-out (five minutes or

more) will also cause a System Fail alarm.

BLENDER DIFFERENTIAL BYPASS ALARM

(Optional). The Blender Module (factory installed

option) will alarm and bypass whenever the pressure differential between the 02 and Air supplies exceeds 30 psi f2 psi. When this condition occurs, the

blender will continue to supply whichever gas is the

higher pressure: either 100% Air or 100% Oxygen.

This is an audible alarm only. There are no visual indicators.

3.2.8 APGAR TIMER

BABY TEMPERATURE. When the temperature

sensed by the Skin Temperature Probe is 1

“C

above or 1 “C below the selected Set Temperature

Display setting (in Baby Mode), the Baby Temp Indicator will flash and an audible alarm will sound,

When the Apgar Timer is running, the Apgar Timer

Display will show elapsed minutes and seconds and

the audible alarm will sound at the l-,

5- and

1 O-minute Apgar time intervals.

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Page 21

RESUSCITAIRE~ BIRTHING ROOM WARMER

SECTION 4

OPERATION

4.1 CONTROLS, INDICATORS AND

CON-

NECTORS

Controls, Indicators and Connectors for the

Control-

ler are presented in Figures 4.1 and 4.2 and Tables

4.1 and 4.2. Controls, Indicators and Connectors for

the Resuscitation Module are presented in Figure

4.3 and Table 4.3.

FIGURE 4.1 CONTROLLER FRONT PANEL: CONTROLS, INDICATORS AND

CONNECTORS

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Page 22

RESUSCITAIR~ BIRTHING ROOM WARMER

TABLE 4.1 CONTROLLER FRONT PANEL: CONTROLS, INDICATORS AND

CONNECTORS

ITEM

1

2

NAME

DESCRIPTION

Mode

Pre-Warm Indicator

Indicates that the Controller is operating in the

Warm Mode.

Manual Indicator

Indicates that the Controller is operating in the Manual

Mode.

Baby Indicator

Indicates that the Controller is operating in the

Mode.

Mode Select Key

Press to select either Pre-Warm, Manual or Baby

Mode of operation.

Pre-

Baby

/\

8

Skin Temp Probe

Connector

Accepts Skin Temperature Probe for monitoring infant

skin temperature. When connected, the Baby Temperature Display indicates the temperature sensed by the

probe. When probe isdisconnected, the BabyTemperature Display is blank. When disconnected in Baby

Mode, a Probe Alarm also occurs.

>37 “C Key

Press to place Set Temperature Display (refer to Item 9)

in Temperature Override Mode, >37 “C (98.6 “F).

0

>37”C

NOTE: This Key is inactive until the Set Temperature

has been set to 37.0 “C.

5

>37 “C Indicator

Lights to indicate that the Temperature Override Mode,

>37 “C (98.6 OF), has been selected.

6

Keypad Lock Key

7

e

0

Exam Light Key

Press to disable the ~37 “C, Up/Down Arrow and Mode

Select Keys (refer to Items 2, 4 and 8). Press again to

enable the ~37 “C, Up/Down Arrow and Mode Select

Keys. Key lights to indicate that Keypad is locked.

Press to turn on or turn off the Examination Light located

in the Warmer Module.

8

0

Manual Mode

Press the Up Arrow Key to raise heater power from 0% to

100% in 10% increments (refer to Item 11, Heater Power

8 @ @ Display).

Press the Down Arrow Key to lower relative heater power

from 100% to 0% in 10% increments (refer to Item 11,

Heater Power Display).

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Page 23

RESUSCITAIR~ BIRTHING ROOM WARMER

TABLE 4.1 CONTROLLER FRONT PANEL: CONTROLS, INDICATORS AND

CONNECTORS (cont.)

ITEM

DESCRIPTION

NAME

Baby Mode

8

@@

Press the Up Arrow Key to raise the Set Temperatu?e

from 34.0 “C (93 “F) to 37.0 “C (98.6 “F). In the Ternperature Override Mode (refer to Items 4 and 5), press

to raise the Set Temperature from 37.0 “C (98.6 “F) to

38.0 “C (102.2 “F).

Press one time to raise the Set Temperature in 0.1 degree increments. Press and hold to raise the Set Ternperature rapidly.

Press the Down Arrow Key to lower the Set Temperaturefrom 37.0 “C (98.6 “F) to 34.0 “C (93 “F). In the Teriperature Override Mode (refer to Items 4 and 5), press

to lower the Set Temperature from 38.0 “C (102.2 “F) to

37.0 “C (98.6 “F).

Press one time to lower the Set Temperature in 0.1 degree increments, Press and hold to lower the Set Ternperature rapidly.

NOTE: The Up/Down Arrow Keys may be locked by

the Keypad Lock Key (refer to Item 6).

9

10

Set Temperature Display

In Baby Mode, displays the Set Temperature as

selected by the Up/Down Arrow Keys (refer to Item

8) in “C or “F as selected by the “C/OF Key (refer to

Item 12). Display is blank in Pre-Warm and Manual

Modes.

Power Key

Press to turn on or turn off the Controller and Warmer

Module.

-

11

12

Heater Power Display

0

“C/“F

13

Baby Temperature Display

Displays relative heater power in 10% increments from

0% to 100%.

Press to alternately select “C or “F for the Baby Temperature and Set Temperature Displays.

Digital display of infant temperature in “C or “F (referto

Item 12), whether in Manual, Pre-Warm or Baby

Mode. The display is blank if the Skin Temperature

Probe (refer to Item 3) is disconnected from the Controller.

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Page 24

RESUSCITAIREB BIRTHING ROOM WARMER

TABLE 4.1 CONTROLLER FRONT PANEL: CONTROLS, INDICATORS AND

CONNECTORS (cont.)

ITEM

14

Silence/Reset Key

w

@

15

16

DESCRIPTION

NAME

Procedural Silence

Indicator

M

Alarms

Baby Temp

High Temp

In Manual Mode

Press to silence the High Temp Alarm (refer to Item 16)

for 2 minutes.

Resets Chk Patient Alarm (refer to Item 16), and silences Audible Alarm at any time after 10 minutes of

Manual Mode.

Resets Chk Patient Alarm (refer to Item 16), silences

Audible Alarm and restores heater power after the

15-minute Manual Mode period is complete.

In Baby Mode

Press to silence the High Temp Alarm (refer to Item 16)

for 2 minutes.

Press to silence Baby Temp (refer to Item 16) Alarm for

10 minutes.

During non-alarm conditions, press to enter Procedural Silence (refer to Item 15).

When illuminated, indicates thatthe unit is in Procedural

Silence. Procedural silence interval is 5 minutes. During

Procedural Silence, the Baby Temp Alarms are

blocked.

The Baby Temp Indicator will flash with a three-level

audible alarm to indicate that the baby’s skin temperature is more than 1 “C above or below the selected Set

Temperature (refer to Item 9). Press Silence/Reset

Key to silence alarm for 10 minutes.

The High Temp Indicator will flash, the audible alarm

will sound continuously, and the heater will be turned off

when the Skin Temperature Probe is attached to the infant and the skin temperature exceeds 39.0 “C. High

Temp (39.0 “C) Alarms can only be silenced for two minutes by the Silence/Reset Key.

Press the Silence/Reset Key to silence the audible

alarm for 2 minutes.

The Alarm condition is corrected when the temperature

falls to 38.5 “C; the alarm will automatically reset.

Probe

When in Baby Mode, if the Skin Temperature Probe

fails, the Probe Indicator will flash and a three-level

audible alarm will sound. After the Alarm condition is

corrected (the Skin Temperature Probe is replaced),

the alarm will automatically reset. Also refer to Table

5.1)

When in Baby Mode, if the Skin Temperature Probe

fails (shorted probe), the System Fail Indicator will light

and an audible alarm will sound. This Alarm cannot be

silenced. The Power MUST BE TURNED OFF then

ON to reset the alarm condition.

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Page 25

RESUSCITAIRE~ BIRTHING ROOM WARMER

TABLE 4.1 CONTROLLER FRONT PANEL: CONTROLS INDICATORS AND

CONNECTORS (cont.)

16

DESCRIPTION

NAME

ITEM

Alarms (Cont.)

Chk Patient

System Fail

When in the Manual Mode, if the Warmer is in operation

for longer than 10 minutes, the Chk Patient Indicator will

illuminate and the audible alarm will sound one time.

Thereafter, the Chk Patient Indicator will remain on and

the audible alarm will sound every 30 seconds for the next

5 minutes. If at the end of 5 minutes (15 minutes total) the

alarm has not been acknowledged by pressing the Silence/Reset Key (refer to Item 14), the heater will be shut

down and a three level audible alarm will sound continuously.

When an internal malfunction is detected, the System

Fail Indicator will illuminate and the audible alarm wlill

sound continuously. In addition, an Error Code (ErOO to

Er025) will be displayed in the Baby Temperature Display. When a malfunction is detected, the Controller wiill

automatically perform the self-test function (refer to

para. 4.2 Step 3) to determine if the fault has corrected

itself. If the fault has not corrected itself, the error code

will be displayed until corrected.

This alarm is not resettable and the unit should be referred to qualified service personnel.

NOTE: Error code 023 may be corrected by the Operator; refer to Table 5.1.

Power Fail

When power to the unit is interrupted while the Control-,

ler is on, the Power Fail Indicator will flash and the audi-,

ble alarm will beep. When power is restored to the unit,

the alarm will automatically reset. Push the Power Key

to silence the Alarm.

17

Apgar Timer

When the Apgar Timer (refer to Item 18) is running, the

Apgar Timer displays elapsed minutes and seconds

5- and

and the audible alarm will sound at the l-,

1 O-minute Apgar Time intervals.

18

Stop/Start

Press to start or stop the Apgar Timer.

Reset

When timer is runnlng, press to reset the timer to zero

and restart the Apgar count.

0bm

0//

When timer is stopped, press to turn timer off.

NOTE: The Timer can be reset at any time.

- 18-