Respironics BiPAP S User manual

BiPAP System
Service Manual
For Models S, S/T, S-D, and S/T-D
, (SN
RESPIRONICS INC“ |

BiPAP systems are the subject of U.S. Patents #5148802, #523995,#5313937, #5433193, Canadian
Patent #2,024,477, European Patent #EP0425092, German Patent #69021681.5-08, and other
pending U.S. and foreign patents. BiPAP is a registered trademark of Respironics, Inc.
Reorder # 332204 Revision # 1006389
© 1997, Respironics, Inc. All rights reserved.

0 Jable of Contents
Chapter 1 Warnings, Cautions, and Notes
1.1 Wamings ........ inn iii 1-1
1.2 Cautions ae 1-3
1.3 Мо{е$ ..... iiiiieieee rece rovere riceve ceeee venice nie zizi eee ee cene e eee cene ee secco eee eee ce cene sese ce iero iene zi zei ie 1-3
Chapter 2 BiPAP System
2.1 Identifying the BiPAP System Unit.......... i 2-1
2.2 BiPAP System Specifications ui Ree 2-3
2.3 System Description............... eee msesemasenessenenenanan 2-6
2.4 System Components .ee 2-7
Chapter 3 Controls and Set-up
3.1 Controls ОИ 3-1
3.1.1 Front Pame] .et 3-1
3.1.2 Rear Panel Controls i 3-2
3.2 Setting Up the BiPAP System ersen 3-5
3.3 Detachable Control Panel (DCP) (Optional) iii 3-8
3.4 DCP Set-Up iii 3-9
Chapter 4 Maintenance
4.1 Maintenance Schedule. ie 4-1
4.2 Maintenance Procedures............... iii 4-3
4.2.1 Recording the Hours on the Time Meter. iii 4-3
4.2.2 Verifying theVoltage Selector Switch Setting .............. iii 4-3
4.2.3 Changing the Fuses ii 4-3
4.2.4 Test Unit Control Functions. eine cei einen 4-4
4.2.5 Notes to Maintenance Procedures ss. nenene 4-4
4.2.6 Cleanming theBiPAP20 nee eee eee eee eee ee n henna 4-5 |
4.2.7 Changing the Filter. ss 4-6
Chapter 5 Troubleshooting
51 Тгоче$ВооНпое. ....... лилии 5-1
5.1.1 Troubleshooting Chart... iii 5-2
5.1.2 Power Switch Wiring ses ea 5-7
5.1.3 Motor Control Board (MCB) Checks i 5-7
5.1.4 Blower Assembly Checks i 5-8
5.1.5 Transformer Checks sise 5-9
BiPAP Service Manual i

Chapter 7 continued
7.15 Verify Zero Function (S-D and S/T-D) ss 7-22
7.15.1 Test Equipment Set-Up................... sienne 7-22
7.15.2 BiPAP Set-Up....................... inner 7-22
7.15.3 Test Procedure... sienne τον 7-22
7.16 Verify Calibrate Function (S-D and S/T-D) hs 7-23
7.16.1TestEguipmentSet-up.......................... eee 7-23
7.16.2 BiPAP Set-Up...... ie 7-23
7.16.3 Test Procedure......................... ii 7-23
7.17 DCP Verification (S-D and S/T-D) eee 7-24
Z.17.1 Test Equipment SetUD ini 7-24
7.17.2BiPAPSet-up.............. eee 7-24
7.17.3 TestProcedure.................e sise 7-24
7.18 Corrective ActonS iii 7-25
Chapter 8 Parts List and Exploded Views |
8.1 Wraparound Assembly ............ errnrnkee 8-1
8.2 Exploded View iii 8-2
8.3 Exploded View—Foam Panels.…..….................................... ss 8-4
Appendix A Required Tools and Equipment
А.1 Service Tools sise A-1
A.2 Service SUPpli8S .ocococnonoconinncnnononcncnacrnnancannnnononcnnnnonan caer conan onanan ener caca conan ener encara orar naar ronnenso A-2
A.3 Acceptable Electronic Test Equipment reee onen ee A-3
A.3.1 Flowmeter ii A-3
A.3.2 Oscilloscope suisses A-3
A.3.3 Digital Manometer ii A-3
A.3.4 Wattmeter iii RSK KOA E RSK E EE A ERA R EA R KA AK A-3
Appendix B Data Sheets... ee B-1
Appendix C BiPAP Screening Procedure
C.1 BiPAP Screening Procedure sise eee een tn C-1
Appendix D DC Operation.............................. re D-1
Appendix E BiPAP 20 System Schematics
E.1 Wiring Diagram............ ини ини: E-1
E.2 Schematic Statement.............. eee iii 0 eo Ke Renee een E-1
Appendix F Changes... nn René F-1
iv
BiPAP
Service
Manual

9 Chapter 1 Warnings, Cautions, and Notes
1.1 Warnings
1.2 Cautions
1.3 Notes
BiPAP Service Manual

Warnings, Cautions, and Notes 1-1
Chapter 1: Warnings, Cautions, and Notes
WARNING: Indicates the possibility of injury to the patient or the operator.
CAUTION: Indicates the possibility of damage to the device.
NOTE: Places emphasis on an operating characteristic.
1.1 Warnings
General
e This is a service manual. It does not provide adequate information to allow proper operation of
the device for use in treating patients. Please refer to the device Clinical, Dealer, and/or Patient
Manuals for clinical use.
e This manual serves as a reference. It should be used in conjunction with the instructions and
protocol set by the physician at the institution where the device is being used. The instructions in
this manual are not intended to supersede established medical protocols regarding the use of
assist ventilators.
Safety
e The information contained in this section is supplemental to the warnings, cautions, and notes
contained in the Clinical, Dealer, and/or Patient Manuals for each device. Please read the
appropriate device manuals prior to servicing the unit.
e The BiPAP System is intended for use on adult patients (2 30 kg) only.
* The BiPAP System is intended for use with a Respironics, Inc. approved patient circuit only. A
Respironics approved circuit consists of :
ο. smooth inner lumen tubing;
e anexhalation device such as the Whisper Swivel® or Respironics Disposable
Exhalation Port Assembly; and
e anoninvasive patient interface (nasal mask, mouthpiece, or full face mask).
Additional accessories may be added to the circuit to meet specific needs. Every time changes
are made to the circuit configuration, the delivered pressures must be monitored at the patient
connection with the unit cycling.
‧ When operating the BiPAP S/T-D System with the Detachable Control Panel (DCP), the DCP
settings override the settings on the BiPAP S/T-D System’s control panel. DO NOT connect the
DCP to the BiPAP S/T-D System while the unit is turned on.
* Explosion Hazard - Do not use the BiPAP System in the presence of flammable anesthetics.
* Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of
an open flame.
+ DO NOT add oxygen to the front of a BiPAP unit (at the inlet filter opening).
BiPAP Service Manual

Warnings, Cautions, and Notes
RS
Warnings continued
Operation
BiPAP System performance should be verified, as described in the Clinical Manual, before each
new patient is placed on the system.
The addition of accessories to the patient circuit (e.g., heated humidifier, bacteria filter, water
traps, and additional tube lengths) degrades pressure and flow delivery at the patient connection.
Confirm that the delivered pressures and flows are adequate for patient management when
circuit accessories are used. It may be necessary to increase pressure delivery to compensate for
the increased resistance of the circuit.
When the BiPAP System is used with a heated humidifier, that manufacturer’s specifications
should be checked to confirm that the humidifier will function correctly in the presence of the
continuous flow from the BiPAP System. Always position the humidifier lower than both the
BiPAP unit and the patient.
Never attach oxygen tubing or any positive pressure source to the Pressure Port on the front
panel of the BiPAP S/T-D unit.
Service
Wiring connections and adjustments should be performed by authorized service personnel
ONLY.
Repairs and adjustments MUST be performed by experienced personnel who are fully ac-
quainted with this equipment. Service done by inexperienced, unqualified personnel or installa-
tion of unauthorized parts could cause personal injury, invalidate the warranty, or result in costly
damage. Contact Respironics, Inc. or your health care dealer if the unit fails to meet performance
specifications.
To avoid electrical shock, disconnect the electrical supply before changing the fuses.
Replace fuses with those of the same type and rating only.
Cleaning
To avoid electrical shock, unplug the BiPAP unit before cleaning it.
BiPAP Service Manual

Warnings, Cautions, and Notes 1-3
1.2 Cautions
{ CAUTI
ON: Federal law restricts this device to sale by or on the order of a physician. D
i
The DCP cable connector port is NOT a standard computer communications port.
Connecting the output port to a computer could damage the computer and the BiPAP unit.
On BiPAP S/T-D models, output signal pin connections are active. Care must be exercised to
prevent electrical shorting between the pin connections.
Only Respironics cables should be used. Use of any other cable types may cause damage to the
BiPAP S/T-D System.
For pressure monitoring, use only tubing with a smooth inner lumen.
When transporting or storing the BiPAP System, precautions should be taken to avoid exposure
to temperature extremes. If exposure to such temperatures has occurred, the unit should be
allowed to come to room temperature before being turned on.
The unit should be positioned on its base or rear panel for proper operation.
The voltage selector switch must be set according to local line voltage and the proper fuses used.
When using Respironics smooth inner lumen tubing without a heated humidifier, the overall
length of the tubing should not exceed twelve feet.
Regularly inspect the DCP cable.
Electromagnetic emissions: BiPAP Systems have been tested and shown to comply with FCC
Class B Subpart 15.J requirements and the IEC 601-1-2 requirements for electromagnetic
compatibility.
Operational verification of medical monitoring equipment used near the BiPAP System is recom-
mended to assure that any electromagnetic interference produced by the System unit does not
affect the function of the monitoring equipment.
1.3 Notes
The Inspiratory Positive Airway Pressure (IPAP) and Expiratory Positive Airway Pressure
(EPAP) controls are electrically coupled. The unit will not deliver an EPAP level that is higher
than the set IPAP level. If the EPAP control is set higher than IPAP, the unit will be locked to the
IPAP setting and the IPAP Light Emitting Diode (LED) will remain lit.
Circuit tubing with a smooth inner lumen and a nominal diameter of 22 mm is recommended.
Tubing with a corrugated inner lumen will cause a pressure drop from the blower outlet to the
patient connection. This may affect the unit's ability to deliver the maximum pressure.
Heat and moisture exchangers should not be used with the BiPAP System. Testing has shown
that the ability of the unit to maintain the prescribed pressure is significantly affected by the
addition of a heat and moisture exchanger to the patient circuit.
Additional Warnings, Cautions, and Notes are located throughout this manual.
BiPAP Service Manual

Chapter 2 BiPAP System
2.1 Identifying the BiPAP System Unit
2.2 BiPAP System Specifications
2.3 System Description
2.4 System Components
|
;
BiPAP Service Manual |

Part Numbers 2-1
2.1 Identifying the BiPAP System Unit
© Respironics identifies units with two numbers: the Model Number and the Part Number.
The Model Number is printed on a label on the bottom left of the rear end cap.
The Part Number (also known as the finished goods number) is indicated on thiş list by model number. The
Part Number is the number used to order the BiPAP system, and is the number that must be used if a unit is
returned to Respironics.
Part Number Product Description
Model 332003
332110
BiPAP S/T-D — US/CAN Clinical System
332098 BiPAP S/T-D — US/CAN Research Demo
332105 BiPAP S/T-D — US/CAN Clinical Demo
332268 BiPAP S/T-D — US/CAN Hospital Core Package
332305 BiPAP S/T-D — CSA Clinical System with DCP
Model 332083
332407 BiPAP S/T-D — Australian System
332055 BiPAP S/T-D — International Clinical System
8 332266 BiPAP S/T-D — LGA Hospital Core Package
332099 BiPAP S/T-D — International Clinical Sample
332392 BiPAP S/T-D — International Hospital Core Package
Model 332109 NOTE: As of S/N 28235, Model 332109 is obsolete
332074 BiPAP S/T Home Starter Kit — US Home System
NOTE: As of S/N 28235, Part Number 332074 becomes US/CAN Home System; see
Model Number 332203
Model 332203
332056 BiPAP S/T — CAN Home System
NOTE: As of S/N 28235, Part Number 332056 is obsolete
332074 BiPAP S/T — US/CAN Home System — As of S/N 28235
Model 332108
332054 BiPAP S/T — International Home System
332406 BiPAP S/T — Australian Home System
Model 332408
332409 BiPAP S/T — LGA Home System
BiPAP Service Manual

Part Numbers
D ep
Part Number
Model 332092
332069
332146
332212
332262
332303
332298
Model 332095
332023
332304
332405
Model 332019
332100
Model 332079
332073
332404
Model 332202
332072
332100
Model 332252
332231
Model 332201
332197
Product Description
BiPAP S-D — US/CAN Clinical System
BiPAP S-D — US/CAN Sample
BiPAP S-D — Unit Sample
BiPAP S-D — US/CAN Sample
BiPAP S-D — US/CAN Clinical System with DCP
BiPAP S-D — Clinical Sample with DCP
BiPAP S-D — International Clinical System
BiPAP S-D — TUV Clinical System with DCP
BiPAP S-D — Australian Diagnostic System
NOTE: As of S/N 28329, Model 332019 is obsolete
BiPAP S— US Home System
NOTE: As of S/N 28329, Part Number 332100 becomes US/CAN Home System; see
Model 332202
BiPAP S — International Home System î `
BiPAP S — Australian Home System |
BiPAP 5 — CAN Home System
NOTE: As of S/N 28329, Part Number 332072 is obsolete
BiPAP S — US/CAN Home System — As of S/N 28329
BiPAP S/T — International Xemko Home System
BiPAP S — International Xemko Home System
BiPAP Service Manual

<
System Specifications 2-3
2.2 BiPAP System Specifications
MODELS: S/T, S/T-D, S, SD
FUNCTIONS:
IPAP onen Delivers set pressure continuously.
(IPAP-Inspiratory Positive Airway Pressure)
EPAP ss Delivers set pressure continuously.
(EPAP-Expiratory Positive Airway Pressure)
The IPAP and EPAP controls are electrically coupled. The unit will not
deliver an EPAP level that is higher than the set IPAP level. If the EPAP
control is set higher than IPAP, the unit will be locked to the IPAP
setting and the IPAP Light Emitting Diode (LED) will remain lit.
Modes es Spontaneous Mode (all models)
Spontaneous/Timed Mode (S/T and $/T-D models only)
Timed Mode (S/T and S/T-D models only)
ZELO iii (S/T-D and S-D models with DCP only): Provides “0” reference signal
tothe V ,V_ and VT channels. Circuit pressure is controlled by the
EPAP setting.
Cal. Lu. iii (S/T-D and S-D models only): Provides an alternating square
wave signal with a period of four seconds and an amplitude of +0.5V to
the V „and Ý channels. Sends a corresponding triangular wave
volume signal of 0.5V, to the VT channel. Circuit pressure is controlled
by the EPAP setting.
PRESSURES AND FLOW
CHARACTERISTICS
(all models):
Pressure range for IPAP or EPAP
Pressure Calibration Accuracy ....
Pressure Setting Stability ..............
4cm HO to 20 cm HO at +60 L/min flow*
Pressure controls are electronically coupled so that the unit will not
deliver a higher EPAP than IPAP level.
22 cm HO of the indicated control setting.
+1 cm H,0 over 8 hours.
(fore
*Measured at the end of a six-foot section of smooth inner lumen tubing.
All pressure measurements were made at the blower outlet
unless stated otherwise.
BiPAP Service Manual

2-4 System Specifications
CYCLING:
Breaths Per Minute ーーーーーー……
Breathing Rate Accuracy
% IPAP Setting Accuracy
MinimumIPAPTime...............................
Maximum IPAP Time
Minimum EPAP Time.........................
Spontaneous Inspiratory Effort Threshold
(S/T and S/T-D units only): 4 to 30 BPM.
(S/T and S/T-D units only): +10% or 2 BPM of indicated
reading, whichever is greater.
(S/T and S/T-D units only): 10 to 90%.
(S/T and S/T-D units only): +10% of indicated setting.
(all units): Approximately 200 msec (Spontaneous and Sponta-
neous / Timed modes only).
(all units): 3 seconds +0.5 second at a constant flow rate condi-
tion of 100 liters/min (Spontaneous and Spontaneous /Timed
modes only).
(all units): 500 msec +75 msec (Spontaneous and Spontaneous/
Timed modes only). '
(all units): 47.5 cc/sec above the average leak flow rateof 14L/
min, maintained for 30 msec (Spontaneous and Spontaneous/
Timed modes only).
PATIENT CIRCUIT:
Whisper Swivel Continuous Leak Rate ....
Nominal Leak
14 L/min (nominal)
21 L/min (nominal)
26 L/min (nominal)
30 L/min (nominal)
Pressure
5 cm H,0
10 cm H,0
15 cm H,0
20 cm H,0
ELECTRICAL REQUIREMENTS:
Current Consumptions:
Electromagnetic Emissions:
Fuse Ratings: Serial Numbers<200,000
Serial Numbers>200,000
100-130 VAC (60Hz) or 200 to 260 VAC (50Hz).
(Voltage range set by voltage selector switch on rear panel.)
800mA max. for 100 to 130 VAC
400mA max for 200 to 260 VAC
Designed to ECRI Electical Safety Specifications.
Ground Continuity: <500 milliohms (45 typical)
Current Leakage: <100 microamps (8.2 typical)
BiPAP Systems have been tested and shown to comply with FCC
Class B Subpart 15.] requirements and the IEC 601-1-2 require-
ments for electromagnetic compatibility.
1A Fuses -- 115 Volt Electrical Systems
500mA Fuses -- 230 Volt Electrical Systems
800mA Fuses --115 Volt Electrical Systems
400mA Fuses -- 230 Volt Electrical Systems
OPTIONAL DCP CABLES:
26 AWG (minimun) tinned copper, shielded, insulated wire.
BiPAP Service Manual

System Description 2-5
PHYSICAL CHARACTERISTICS:
<
Unit dimensions... 7x9 x 12 6 inches (20 x 23 x 31 cm).
850 cubic inches (13,931 cubic cm).
Weight... mere 9.5 lbs (4.3 kg).
Operating Temperature... 50 to 100 °F (10 to 38 °C). |
Storage Temperature... n -20 to 140 °F (-30 to 60 °C).
Outlet Temperature... It is normal for the pre-foam BiPAP unit to have an outlet air
temperature that is 10 to 12 °F warmer than room temperature,
especially after running all night. A difference between room
temperature and air outlet temperature greater than 18 °F is an
indication for a service check. Foamed units (serial numbers
052000 or greater) can be expected to have an outlet air
temperature that is 18 to 25 °F warmer than room temperature,
especially after running all night. A difference between room
temperature and air outlet temperature greater than 25 °F is an
indication for a service check on a foamed BiPAP unit. The air
temperature at the end of a patient circuit will always be lower
than the temperature measured at the outlet and is typically 5 to
10 °F above ambient.
Noise Level... eee Variables associated with noise measurement are numerous and
à therefore no specification is provided.
BiPAP Service Manual

2.3 System Description (
This BiPAP unit provides bi-level positive airway pressure, through a nasal or nasal /oral mask, to assist
patient ventilation. An integral flow transducer senses whether the patient is inhaling or exhaling by con-
stantly monitoring the amount of air flowing through the system. The system then provides the appropriate
amount of positive air pressure for the function, i.e., more pressure during inhalation (IPAP), less pressure
during exhalation (EPAP).
The unit is available in four models: BiPAP S, BiPAP S/T, BiPAP S-D, BiPAP S/T-D.
The BiPAP S unit offers two modes of operation:
e CPAP (Continuous Positive Airway Pressure) - When the control is set to either IPAP or EPAP, the unit
provides continuous pressure at the level you set for that function.
* SPONTANEOUS - The unit cycles between inhalation (IPAP) and exhalation (EPAP) levels as triggered
by patient breathing.
The BiPAP S/T offers four modes of operation:
CPAP (Continuous Positive Airway Pressure) - When the control is set to either IPAP or EPAP, the unit
provides continuous pressure at the level you set for that function.
SPONTANEOUS - The unit cycles between inhalation (IPAP) and exhalation (EPAP) levels as triggered
by patient breathing.
SPONTANEOUS/TIMED - As with the SPONTANEOUS mode, the unit cycles between IPAP and EPAP
levels as sensed from patient breathing, but if the patient does not inhale within a preset time interval,
the unit cycles to IPAP. The time interval is determined by the BPM (breaths per minute) setting on the
contro] panel.
TIMED - The unit cycles between IPAP and EPAP levels at preset time intervals, determined by the BPM
and % IPAP (percent of breath cycle spent in IPAP settings on the control panel).
The BiPAP S-D unit offers the same operating modes as the BiPAP S, but all functions can be controlled by a
Detachable Control Panel (DCP). In addition, the following DC analog output signals are provided for a
recorder or oscilloscope:
P (Pressure) - The signal from the internal pressure transducer indicates IPAP and EPAP levels (in
cm HO at the measure point in the patient circuit).
* Vr(Estimated Tidal Volume) - Signal from the internal flow transducer indicates volume of air (in liters)
inhaled or exhaled with each breath during quiet breathing.
9 VAR (Total Fiow Rate) - The signal from the internal flow transducer indicates total air flow rate (in L/
min) through the unit to the patient circuit. Total air flow consists of the air flow necessary to satisfy
circuit leaks (V,,,,), and patient breathing (V,,).
¢ V.., (Estimated Patient Flow Rate) - The signal from the internal flow transducer indicates patient flow
rate (in L/min). The data is based on Total Flow Rate (V,,,) minus Estimated Leak Flow Rate Wo) i
BiPAP Service Manual

System Components 2-7 |
RS
The BiPAP S/T-D unit offers the same operating modes as the BiPAP S/T, but all functions can be controlled
by a DCP. In addition, it provides the same recorder output signals (V,,V,, V., and P) as the BiPAP
S-D. ーー
The Airway Pressure Monitor is designed to supplement patient monitoring during ventilation with the
BiPAP S/T-D System. Its purpose is to notify medical personnel and/or user of undesirably LOW (as in a
disconnect situation) or HIGH pressures at a specific point in the breathing cycle.
Optional Detachable Control panels (DCP) are available for the BiPAP S/T-D and the BiPAP S-D units. They
allow all control settings to be made and/or adjusted remotely. Some units may use the Remote Control Unit
(RCO). All information relating to the DCP is applicable to the RCU.
Model |
Feature 5 S-D SIT S/T-D
CPAP Y Y Y Y
Spontaneous Y Y Y Y
Spontaneous/Timed N N Y Y
Timed N N Y Y
DCP Contol N Y N Y
The table above indicates which features are present in the BiPAP model you are using. A "Y" in the column
means that feature is present in that model. A "N" means that that feature is not present in that model.
BiPAP Service Manual

2-8
System Components
2.4 System Components
Figure 2-1 shows the main system components, and Figure 2-2 shows the system air flow.
Flow Transducer i
i / TN „TX À Ί Y - .
|
;
/
{
)
(
)
\
i
|
To
Patient
|
Raw
Flow
Signal
/
y
+
TU
A
Circuit
IE
|
BiPAP | Motor Drive «— —
Controls | = poe and Position 一
ot
pl)
tower
Signals
©
Blowe
ER TTT т
+ i |
8: |Brushless DC Motor | : 7 1
| : Controller Board i и /
O | Assembly and y /
< Unregulated DC < /
a Power Supply ーー / Lin TUTI .
> ΣΤΕ ΕΕ ΤΕΕ ha Ambient
MAA À AKL O
| SI | = VIE = Air
| ÇİN E
|
a
LIS
>
12 VAC 12 VAC M TV <
| ! A
! : = ^
_ — E PA Valve Muffl à
© uiller
E 3 Ela 115 VA 115 VAC
σ
= 中 s o Ly Voltage Selector
È a Fuses L |
Sup 115/220 VAC 一 一
の の
고 ©
2 $
š 8
の (の
A
Figure 2-1. System Components.
i
BiPAP Service Manual

2-9
Blower Outlet
Blower
Assembly
Figure 2-2. System Air Flow.
BiPAP Service Manual