Dräger Gamma - Service Manual

Download as pdf or txt
Download as pdf or txt
You are on page 1of 95
At a glance
Powered by AI
The document discusses technical service manuals and testing procedures for Dräger Gamma/Gamma XL patient monitors.

The document provides information on technical service, product overview, technical specifications, monitor controls, and testing procedures for Dräger Gamma/Gamma XL patient monitors.

The monitor can measure ECG, respiration, SpO2, temperature, etCO2 (if installed), non-invasive blood pressure, and invasive blood pressure parameters.

Technical Service Manual

Gamma / Gamma XL Patient Monitors


Monitor System

Revision 0
6013.053
MS14879

Emergency Care OR/ Anesthesia Critical Care Perinatal Care Home Care Because you care
Copyright by Drger Medical AG & Co. KGaA, Lbeck, Germany.

No reproduction allowed for commercial purposes.

Read and understand the Instructions for Use/Operators Manual.

This Technical Documentation does not replace the Instructions for Use/Operators
Manual.

The warranty and liability conditions of the general terms and conditions for business
transactions of Drger Medical AG & Co. KGaA are not extended by this Technical
Documentation.

Observe all applicable technical laws and regulations.

Insofar as reference is made to laws, regulations or standards, these are based on the
legal system of the Federal Republic of Germany. Observe the laws and regulations
applicable in your country.
Contents

General

1 Advisory 3

2 Important information 3

2.1 Symbols and Definitions ......................................................................................................... 3

3 Introduction 4

3.1 Service Strategy ..................................................................................................................... 4

4 Product Overview 5

4.1 Monitored Patient Parameters ................................................................................................ 5

4.2 Gamma/Gamma XL Monitor Controls .................................................................................... 5

4.3 TFT-LCD Display .................................................................................................................... 5

4.4 Alarms .................................................................................................................................... 5

4.5 Monitor/Software Tracking ...................................................................................................... 6

5 Technical Data 6

5.1 General ................................................................................................................................... 6

5.2 Environmental ........................................................................................................................ 6

5.3 Display .................................................................................................................................... 7

5.4 Outputs ................................................................................................................................... 8

5.5 Connectors ............................................................................................................................. 8

6 Monitor Controls 9

6.1 Main Screen Key .................................................................................................................... 9

6.2 Menu Key ............................................................................................................................... 9


All rights reserved. Copyright reserved.

6.3 Alarm Limits Key .................................................................................................................. 10

6.4 Alarm Silence Key ................................................................................................................ 10

6.5 All Alarms Off Key ................................................................................................................ 10


K6013053IECIVZ.fm 03.12.04

6.6 NBP Start/Stop Key .............................................................................................................. 10

6.7 Fast Access Key ................................................................................................................... 10

6.8 Record Key ........................................................................................................................... 10

Drger Medical AG & Co. KGaA Contents I


Contents

Function Description

1 Overview 15

2 Parameter Inputs 15

3 Main PC Board 15

3.1 LCD Control .......................................................................................................................... 16

3.2 Network Interface ................................................................................................................. 16

3.3 Front Panel Circuitry ............................................................................................................. 16

3.4 Pod Interface ........................................................................................................................ 16

3.5 Battery Control and ON/OFF Control ................................................................................... 16

3.6 BOOT Process, Flash Memory, and DRAM ......................................................................... 16

3.7 SRAM ................................................................................................................................... 17

3.8 68HC912D60A Microcontroller ............................................................................................. 17

4 Front End 17

4.1 NBP Control .......................................................................................................................... 17

4.2 Safety ................................................................................................................................... 17

5 Physiological Parameter Data Acquisition 18

5.1 ECG/Resp ............................................................................................................................ 18

5.2 Respiration ........................................................................................................................... 20

5.3 SpO2 ..................................................................................................................................... 21

5.4 Invasive Blood Pressure .......................................................................................................23

5.5 Non-Invasive Blood Pressure ............................................................................................... 24

5.6 Temperature Circuit .............................................................................................................. 27


All rights reserved. Copyright reserved.

6 etCO2 Pod 28
K6013053IECIVZ.fm 03.12.04

7 Power Supply System 29

7.1 Main Battery ......................................................................................................................... 29

7.2 AC Power Adapter ................................................................................................................ 30

II Drger Medical AG & Co. KGaA Contents


Contents

Maintenance Procedures

1 Maintenance Procedure 33

1.1 General ................................................................................................................................. 33

1.2 Battery .................................................................................................................................. 33

1.3 Replacing NBP Air Intake Filter ............................................................................................ 33

1.4 Safety and Function Tests .................................................................................................... 34

1.5 Acceptance Test Report ....................................................................................................... 45

Schematics and Diagrams

1 IBP Connector 49

2 MultiMed Pod Connector 49

3 Docking Station Connector 50

4 Alarm Cable (Unterminated) 50

5 Interface Plate Connector 51

6 Recorder/Alarm Y-cable 51

7 Infinity Docking Station Connectors 52

8 PodPort Connector Pins 53

Fault-Cause-Remedy
All rights reserved. Copyright reserved.

1 Troubleshooting 57

1.1 Power Problems ................................................................................................................... 57


K6013053IECIVZ.fm 03.12.04

1.2 Optical Encoder Malfunction ................................................................................................ 59

1.3 TFT-LCD Display Malfunction .............................................................................................. 59

1.4 Fixed Key Fails to Function .................................................................................................. 60

Drger Medical AG & Co. KGaA Contents III


Contents

1.5 Visual or Audible Alarm Reporting Failure ............................................................................ 60

1.6 NBP Malfunction ................................................................................................................... 60

1.7 etCO2 Malfunction ................................................................................................................ 61

1.8 No Printout from Recorder .................................................................................................... 62

1.9 Isolating Cable Malfunctions ................................................................................................. 63

1.10 Patient-Related Data Not Retained or Monitor Fails to Compute Trends ............................. 63

Annex

Spare parts list

Test List

Problem Report

All rights reserved. Copyright reserved.


K6013053IECIVZ.fm 03.12.04

IV Drger Medical AG & Co. KGaA Contents


General

1
2
Gamma / Gamma XL Patient Monitor General

General

1 Advisory This document corresponds to the version/revision level effective at the time
of system delivery. Revisions to hardcopy documentation are not automati-
cally distributed.

The installation and service of equipment described herein is to be performed


by qualified personnel who are employed by Drger Medical or one of its affil-
iates or who are otherwise authorized by Drger Medical or one of its affili-
ates to provide such services.

Assemblers and other persons who are not employed by or otherwise directly
affiliated with or authorized by Drger Medical or one of its affiliates are
directed to contact one of the local offices of Drger Medical or one of its affil-
iates before attempting installation or service procedures.

2 Important informa- This Technical Documentation/Service Manual conforms to the International


tion Standard IEC 60601-1.

Read each step in every procedure thoroughly before beginning any test.
Always use the proper tools and specified test equipment. If you deviate from
the instructions and/or recommendations in this Technical Documentation/
Service Manual, the equipment may operate improperly or unsafely, or the
equipment could be damaged.

The maintenance procedures described in this Technical Documentation/


Service Manual may be performed by qualified service personnel only. These
maintenance procedures do not replace inspections and servicing by Drger
Medical.

Strictly follow the Instructions for Use/Operating Instructions! This


Technical Documentation does not replace the Instructions for
Use/Operating Instructions. Any use of the product requires full
understanding and strict observation of the product-specific Instruc-
tions for Use/Operating Instructions.

Unless otherwise stated, reference is made to laws, regulations or stan-


dards (as amended) applicable in the Federal Republic of Germany.

2.1 Symbols and Defini-


tions
All rights reserved. Copyright reserved.

This symbol is used to provide important information that, if ignored,


Gamma_Gamma_XL_SM_General.fm 03.12.04

could lead directly to a patients or operators injury. It is also used to


provide important information that, if ignored, could lead directly to
equipment damage and, indirectly, to a patients injury.

The following three alert levels are used in this documentation to indicate a
hazardous situation and how to avoid it.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 3


General Gamma / Gamma XL Patient Monitor

Danger Danger indicates an imminently hazardous situation


which, if not avoided, will result in death or serious
injury.
Warning Warning indicates a potentially hazardous situation
which, if not avoided, could result in death or serious
injury.
Caution Caution indicates a hazardous situation which, if not
avoided, may result in minor or moderate injury. Caution
may also be used to alert against unsafe practices.

Danger
Danger indicates an imminently hazardous situation which, if not
avoided, will result in death or serious injury.

Note
This symbol is used to provide additional information, operating tips, or
maintenance suggestions.

Definitions according to German standard DIN 31051:


Inspection = examination of actual condition
Servicing = measures to maintain specified condition
Repair = measures to restore specified condition
Maintenance = inspection, servicing, and repair

3 Introduction In keeping with the service strategy for the Infinity Gamma Patient Monitor
and the Infinity Gamma XL Patient Monitor, this technical manual provides
the necessary information required to maintain a Gamma/Gamma XL Patient
Monitor in the field. The Gamma and Gamma XL are both stationary and por-
table monitors designed to monitor patient vital signs (refer to users guide for
monitoring options). For stationary operation near a bedside, the monitor is
connected to an AC/DC power adapter or placed on a specially designed
docking station attached to a shelf, wall, or rolling stand that securely locks it
into place. While on the docking station, the monitor is powered by an IDS
power supply. When the monitor is detached from an IDS, it is powered by a
lead acid battery or by an optional Lithium ion battery. The monitor is reat-
tached to the AC/DC Power Adapter or placed back on an IDS to recharge
the battery.
All rights reserved. Copyright reserved.

3.1 Service Strategy The monitor has been designed for high reliability, with an estimated MTBF of
Gamma_Gamma_XL_SM_General.fm 03.12.04

50,000 hours (5.7 yrs.) of continuous operation.Therefore, the service strat-


egy is based on few failures in the field, a clear definition of failure analysis by
field service personnel, and a quick repair turnaround. The field repair philos-
ophy is based on the distributed and approved spare parts list.

This manual is intended to serve as a source of technical information, for


qualified field service personnel to use in maintaining a Gamma/Gamma XL
patient monitor in accordance with the Drger Medical Service Strategy. Field
service is expected to be successful First-Time Every Time.

4 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor General

4 Product Overview Gamma and Gamma XL Patient Monitors are light-weight, battery-equipped,
hand-held or semi-permanently mounted devices for general purpose moni-
toring of a preconfigured set of physiological parameters. When not con-
nected to a hospitals main ac power, they use a battery with approxi-mately
1 hours (3 hrs. for Li option battery) of operating time. A power adapter or
IDS, which also charges the battery, can be used to operate the monitor from
the hospitals main ac power circuit.

4.1 Monitored Patient The Gamma/Gamma XL monitors the following physiological parameters:
Parameters ECG (three-lead, five-lead, or six-lead pod)
Respiration
Pulse Oximetry (SpO2 and PLS)
Temperature
NBP
IBP1, IBP2 (locked option)
etCO2 via PodComm Port (locked option)
Arrhythmia
OCRG (locked option)
Dual Lead S-T Segment Analysis (locked option)
Anesthetic Gas Monitoring (Gamma XL only, locked option)

4.2 Gamma/Gamma XL All functions are controlled by a 16-position rotary knob and nine front panel
Monitor Controls fixed keys - Alarm Silence, Record, Alarm Limits, NBP Start/Stop, All Alarms
Off, Fast Access, Main Screen, Menu, and ON/OFF. Turning the rotary knob
locates different menu items, and pressing the knob in selects the item.
Depending on the item selected, pressing the knob in may either bring up
another menu or initiate an action. See Section 5 Technical Data. For detailed
operating instructions, consult the Gamma/Gamma XL Patient Monitor User
Guide applicable to the installed software.

4.3 TFT-LCD Display The Gamma Patient Monitor has a 6.5 inch (16.5cm), 3-channel (optional 4th
channel) color TFT-LCD display. The Gamma XL Patient Monitor has an 8.3
inch (21cm), 4-channel color TFT-LCD display. Waveforms display in Erase
Bar mode at 25 20% mm/s (except for respiration and etCO2 waveforms
which display at 6.25 20% mm/s). All displays for a given parameter (label,
unit of measure, and waveform) are in the same color. If a waveform is not
displayed for a parameter, its label is gray.

4.4 Alarms Alarm limits can be set either on a user-definable setup table, or automatic-
All rights reserved. Copyright reserved.

ally based on current parameter values. Three alarm grades, each with a dis-
tinct alarm tone, announce alarm situations of varying severity, as follows:
Gamma_Gamma_XL_SM_General.fm 03.12.04

life-threatening (asystole or ventricular fibrillation - red)


serious (parameter limit alarms - yellow)
advisory (technical alarms - white)

The message field background and parameter field of the parameter in alarm,
and alarm LED, are displayed in the color associated with the alarm grade as
given above.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 5


General Gamma / Gamma XL Patient Monitor

4.5 Monitor/Software Each monitor has a unique ID chip installed in its rear housing for diagnostic
Tracking and tracking purposes, and un/locking optional software features.

5 Technical Data Technical Data included in this Section is as of publication date of this Man-
ual. Changes are reported in User Guide applicable to installed SW.

5.1 General Table 1 General Specifications

Parameter Specification
Power Requirements 100-250 VAC through AC power adapter
Mains Frequency 50/60 Hz
AC Power Consumption 60 VA AC
Battery Type Lead-acid: PANASONIC LC-T121R8PU or equivalent

Lithium-ion: Drger Medical Li+ Battery Pack


DC Input 11 - 14 V; 32 W continuous, 49 W peak
Battery Operating Time (means running with NBP mea- Lead-acid: 75 mins
surement every 15 min @ 25C temperature, no etCO2
running Lithium-ion: 180 mins
Battery Recharging Time Lead-acid: 5 hours, typical

Lithium-ion: 8 hours, typical


Battery Charge/Discharge/Charge: Lithium-ion only (operating as defined above): 2 hours,
charging for 2 hours, operating 2 hours
Patient Leakage Current <10 A @ 110 V and 60 Hz (per UL 544)

<10 A @ 220 V and 50 Hz (per IEC 601-1)


Chassis Leakage Current with battery eliminator <100 A @ 110 V and 60 Hz (per UL 544)

<500 A @ 220 V and 50 Hz (per IEC 601-1)

5.2 Environmental Table 2 Environmental Specifications

Parameter Environmental Specification


Cooling Method Convection and cooling chimney (no fan)
Temperature:

Operating 0C to +40C (without recorder)


All rights reserved. Copyright reserved.

Storage -20C to +50C


Gamma_Gamma_XL_SM_General.fm 03.12.04

Relative Humidity:

Operating >30% and <95%, non-condensing

Storage >10% and <95% non-condensing

6 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor General

Parameter Environmental Specification


Altitude:

Operating -381 to +3048 m (-1250 to 10,000 ft.)

525 to 795 mmHg (70.0 to 106 kPa)

Storage -381 to 5486 m (-1250 to 18,000 ft.)

375 to 795 mmHg (50.0 to 106 kPa)


Water Resistance Drip-Proof
Gamma Dimensions (H x W x D) 196 x 249 x 134 mm (7.7 x 8.8 x 5.3 in)

Gamma XL Dimensions (H x W x D) 196 x 267 x 147 mm (7.7 x 10.5 x 5.8 in)


Weight:

Gamma Monitor (w/o etCO2) 2.87 kg (6.32 lbs) w/o battery

Gamma XL Monitor (w/o etCO2) 3.32 kg (7.32 lbs) w/o battery

Battery Lead-acid: 0.55 kg (1.22 lbs)

Lithium-ion: 0.35 kg (0.78 lbs)


Finish: Front: white

according to Drger Medical Corporate Design Guide- Rear and Handle: blue
lines
Material: ABS Polycarbonate Blend (injection molded
plastic)

5.3 Display Table 3 Display Specifications

Parameter Specification
Type Color Liquid Crystal Display (LCD)
Size Gamma = 16.5 cm (6.5 in)

GammaXL = 20 cm (8 in)
Resolution 640 x 480 pixels
Active Viewing Area 132.5 x 99.4 mm
Pixel pitch Gamma = 0.207 x 0.207 mm
All rights reserved. Copyright reserved.

Gamma XL = 0.267 x 0.270 mm


Gamma_Gamma_XL_SM_General.fm 03.12.04

Sweep Speeds fixed 25 mm/s 20% for ECG, SpO2, and IBP curves

fixed 6.25 mm/s 20% for Resp and etCO2 curves

fixed 1.0 mm/s 20% for optional OCRG curve


Display Mode Erase bar (updates waveforms from left to right)

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 7


General Gamma / Gamma XL Patient Monitor

5.4 Outputs Table 4 Output Specifications

Parameter Specification
QRS Synchronization:

Timing: For heart rates from 30 to 250 [1/min], with QRS widths
from 40 to 120 msec and QRS amplitudes from 0.5 to 5
Output Pulse: mV, a sync pulse is delayed no more than 35 msec from
peak of R-wave for each valid QRS complex.

+12 V, 100 ms duration


Alarm Output 12 V Open collector output for external alarm indicator
Recorder UART interface w/ recorder through interface plate or
docking station connector
Debug Port UART interface w/ a PC to retrieve diagnostic information
through interface plate or docking station connector
External VGA Video signals sent to external VGA display for remote
viewing of Gamma screen. -- not available when Infinity
Serial Hub interface plate in use.
Export Protocol UART interface w/ external devices using proprietary
export protocol. -- not available when Infinity Serial Hub
interface plate in use.
Network Serial connection to Infinity Network through Infinity LAN
or docking station connector, or with a wireless PC card
in an Infinity Wireless Network.

5.5 Connectors Table 5 Connector Specifications

Parameter Specification
DC Input Drger Medical 2-pin power connector
Docking Station Drger Medical 28-pin connector to provide Alarm Output,
Recorder, Debug Port, Network, External VGA and Power
Memory Card PCMCIA slot
QRS Sync Phone jack connector
MultiMed Pod 16-pin shielded female input connector
IBP 7-pin shielded female input connector
NBP Hose One-hand coupling system
etCO2 7-pin shielded female PodComm connector
All rights reserved. Copyright reserved.
Gamma_Gamma_XL_SM_General.fm 03.12.04

Note

For patient parameter specifications, refer to User Guide applicable to


installed software version.

8 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor General

6 Monitor Controls The rotary knob in the lower right corner of the front panel is a pointing and
selecting device. Turn the knob to select a screen area or menu item or to
change a default value, and press the knob in to confirm your selection and to
set a default value. Press Main Screen key to return to the MAIN screen.

Note

Instructions in this chapter are intended to provide only a cursory overview


of basic monitor controls for accessing and performing service-related
functions. Refer to the User Guide for the installed software version for
complete operating information.

6.1 Main Screen Key Pressing the Main Screen key exits the current menu or screen and displays
the home screen.

6.2 Menu Key -- provides access to Main menu. In general, functions of direct concern to
the FSE or Biomed are accessed via Monitor Setup Biomed on Main
menu. Only authorized personnel should perform password-protected ser-
vice-related functions. Use Biomed password (375) to access the following:
Save Setups - Confirm or Cancel
Locked Options - four locks into which monitor-specific 2-digit codes must
be entered to enable locked options
Diagnostic Logs
Units
a) Temperature - C or F
b) etCO2 - mmHg, kPa, Vol %
c) Pressure - mmHg or kPa
d) ST - mm, mV
Service - requires Service password. (The password is given on the Ser-
vice Setup Instructions for the installed software version.)
a) Update Software Load
b) Test Pulse (Confirm or Cancel - one-shot test pulses for ECG (1mV
spike) and Temp (-5C and +50C, respectively). An additional test is
performed for IBP, Resp Pulse, and SpO2. Test indication is reported
in trend table.)
c) Monitor Setup Language
d) SCIO Port X5
e) USB
f) Data Collection OFF
All rights reserved. Copyright reserved.

g) SpO2
Gamma_Gamma_XL_SM_General.fm 03.12.04

h) NBP
i) Line Frequency 50
j) 60
k) Service
l) Network SetupNetwork Config SSID
m) Central Yes
n) Station No

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 9


General Gamma / Gamma XL Patient Monitor

o) Keep Bed Yes


p) Label No
q) Network WEP Transmit Key
r) Key 1
s) Key 2
t) Key 3
u) Key 4
v) Network Config
w) Network Setup
x) Network IP Address
y) Info Network Setup
z) Service
Exit

Note

Set the line frequency equal to the ac mains line according to local condi-
tions (50 or 60 Hz). An incorrect setting of line frequency can cause artifact
or excessive waveform noise on the ECG waveform.

6.3 Alarm Limits Key -- calls up a setup table for alarms.

1. Turn rotary knob to select desired parameter field and limits, and press
knob in to activate your selection.
2. The number representing the limit value turns black on a blue back-
ground, indicating that you can change it. Turn knob to change value.
3. When desired setting is displayed, press knob in to set value.
4. Press MAIN Screen key to return to MAIN screen.

6.4 Alarm Silence Key -- silences an active alarm tone for 1 minute 5 seconds, and turns active
blinking parameter areas into active steady parameter areas

6.5 All Alarms Off Key -- suspends alarms for a fixed 3-minute 5 second period.

6.6 NBP Start/Stop Key -- starts and stops non-invasive blood pressure measurement.

6.7 Fast Access Key -- allows access to the monitors bottom channel menu as well as tabular
trends, graphical trends and Event recall screen.
All rights reserved. Copyright reserved.
Gamma_Gamma_XL_SM_General.fm 03.12.04

6.8 Record Key -- starts a manual, timed recording on a connected R50 recorder or on a
networked postscript laser printer in an Infinity Network.

10 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor General

Note

If a recorder or networked postscript laser printer is not available, pressing


the Record fixed key writes 15 seconds of waveform and vital signs infor-
mation to internal memory. Monitors can store up to ten recordings, which
are automatically printed as soon as the recorder or networked postscript
laser printer is available.
All rights reserved. Copyright reserved.
Gamma_Gamma_XL_SM_General.fm 03.12.04

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 11


General Gamma / Gamma XL Patient Monitor

All rights reserved. Copyright reserved.


Gamma_Gamma_XL_SM_General.fm 03.12.04

12 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Function Description

13
14
Gamma / Gamma XL Patient Monitor Function Description

Function Description

1 Overview Infinity Gamma and Gamma XL Patient Monitors are configured monitors
running on one processor, an MPC823E Power PC processor, which attends
to all monitoring functions, controls all graphics functions, generates video
and timing signals for the LCD screen, and interfaces with the PCMCIA card
and USB port. It also performs several peripheral control functions, such as
NIBP control, audio volume control, and timing generation for the front end.
See Figure 1.

Figure 1 Infinity Gamma / Gamma XL Patient Monitor Block Diagram


Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

2 Parameter Inputs The data acquisition front end acquires and digitizes signals derived from a
three-, five-, or six-electrode ECG patient lead set, a Nellcor or Masimo
All rights reserved. Copyright reserved.

SpO2 transducer, an Impedance respiration measurement system, a ther-


mistor-based Temperature transducer, and two strain-gauge IBP transducers
(IBP2 = locked option). The NIBP main transducer signal is digitized together
with the rest of the front end parameters. See Section 4 Front End and Sec-
tion 5 Physiological Parameter Data Acquisition for more detailed information.

3 Main PC Board The Main MPC823E Power PC processor not only attends to monitoring
functions, but also controls all graphics functions, generates the video and
timing signals for the LCD screen, interfaces with the PCMCIA card and USB

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 15


Function Description Gamma / Gamma XL Patient Monitor

port, and controls the network link. In addition, it performs a host of peripheral
control functions, such as NIBP control, audio volume control, and timing
generation for the front end.

3.1 LCD Control A set of buffer/drivers are used to drive the 6.5 screen in Gamma monitors or
the 8.3 screen in the Gamma XL monitors. In parallel, a triple video DAC
generates analog RGB signals for an external VGA monitor (typically a CRT
or LCD).

3.2 Network Interface The Infinity Gamma / Gamma XL Monitor interfaces with the physical inter-
face device (e.g., IDS) automatically, when connection to the device has been
detected. Connections to Infinity network services are established and main-
tained by software components resident on both the Gamma and Gamma XL
Monitor and the physical interface device.

3.3 Front Panel Circuitry The front panel circuit processes the audio information, drives the fluorescent
tubes on the LCD, implements a secondary alarm in case the unit resets or
turns off, and routes the video and timing signals to the screen. It also routes
the UART signal coming from the Pod interface to the main board Quad
UART.

3.4 Pod Interface The Pod Interface generates an isolated voltage to power the pod and also
converts the Pod Comm protocol from the pod into a UART stream that can
be interpreted by the microprocessor.

3.5 Battery Control and The Pb-acid or Lithium battery charging and discharging cycles are controlled
ON/OFF Control by a special charger circuit. The circuit initiates a charge cycle when com-
manded by the microcontroller. The charge cycle for a Pb-acid consists of a
bulk charge period in which the battery is being supplied a constant current of
~400mA, a constant voltage period in which the battery voltage is held con-
stant at ~14.8V and the current is allowed to diminish as the charge
approaches 100%, and a float cycle in which the voltage is maintained at
~13.7V. For Lithium batteries, the charger circuit acts as a constant voltage
source of 16.8V. The battery is charged from a switching supply controlled by
the charger chip. The microcontroller also reads the front panel keys and the
rotary knob, encodes the information coming from them, and routes it to the
main processor. When the On/Stdby key is pressed, it turns the monitor on
and off. In addition, the microcontroller controls the NIBP safety timer.

3.6 BOOT Process, The BOOT EEPROM contains the boot code and is preprogrammed at the
Flash Memory, and factory. It can be reprogrammed in the field by means of a special PCMCIA
DRAM card, if required. (Contact your local Drger Medical service representative.)
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

The executable software normally resides as compressed operational code in


Flash memory. When the 68HC912D60A microprocessor senses that the
All rights reserved. Copyright reserved.

on/off switch on the front panel has been pressed, it turns on (or turns off) the
3.3V and 5V supplies. As the 3.3V supply turns on, it wakes up the MPC823E
main processor, which begins execution from the BOOT PROM. During boot
initialization, the main processor attempts to read the Memory Card to detect
authorized software. If a authorized software memory card is present, the
software is loaded from the card. Otherwise, the main processor loads soft-
ware from the Flash to the main processor DRAM, from which it completes
initialization and enters operational mode. DRAM contains expanded opera-
tional code, and data space variables and stacks.

16 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

3.7 SRAM The 512K x 8 SRAM is battery backed up and is used for error logs, trends,
recordings and other non-volatile memory uses.

3.8 68HC912D60A The 68HC912D60A microcontroller, with 64K of EEPROM and 2048 bytes of
Microcontroller RAM, is powered as long as there is a main supply plugged into the system
or when the user presses the ON/OFF button. The code is stored in its inter-
nal flash memory, but can be downloaded from the MPC823E. The microcon-
troller performs the following functions:

On/Off control When the ON/OFF push button (either local or remote is pressed), the micro-
controller activates the 3.3V and 5V supplies, which wakes up the MPC823E
through a power-on reset. In addition, the microcontroller has control over a
flyback supply, which comes on any time the unit is plugged into AC power (in
order to charge the battery) or is turned on.

The microcontroller also reads the front panel keys and the rotary knob,
encodes the information coming from them, and routes it to the main proces-
sor.

NBP Valve modulation When directed by the main processor, the microcontroller supplies modula-
tion signals for the two NBP manifold valves.

NBP Safety Timer When the pump or the valve V2 are turned on, the microcontroller initiates a
128 sec. timer (90 sec. or 60 sec. for neonates) which, if exceeded, produces
an NBP fault and results in cut off of main 12V power to the NBP manifold.

Battery Charger The microcontroller initiates a battery charge when needed, and stops the
charging process when the battery reaches full capacity. It can recognize
whether a Pb or Lithium battery is connected into the system, and directs the
battery controller chip to charge to different levels depending on the battery
type. See Section 3.5 Battery Control and ON/OFF Control. The microcontrol-
ler also acquires the battery voltage and current for monitoring purposes.

Recorder Power The microcontroller controls power applied to a stand-alone R50 Recorder.

Main Audio Generator The microcontroller generates the fundamental audio frequency of the units
tone generator, as directed by the main microprocessor.

USB Power When directed by the MPC823E, the 68HC912D60A microcontroller turns
power ON/OFF on USB buss and determines the transaction speed.

4 Front End All physiological signals (except etCO2) are digitized through a high speed
multiplexing system and a common 16 bit ADC. The data is then transferred
through the isolation barrier to an HDLC port in the main processor, where it
is digitally filtered and processed.

4.1 NBP Control


Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

The NBP main transducer signal is digitized together with the rest of the front
end parameters. However, the redundant (overpressure) transducer is pro-
All rights reserved. Copyright reserved.

cessed separately on the grounded end of the board. The pump on/off signal
and valve enable signals are generated off of the MPC 821 microprocessor.
The PWM signals for the valve flow control and the redundant safety timer
are implemented in a separate microcontroller (MC68HC912D60A).

4.2 Safety Patient isolation withstands 5kV during defib.


Leakage currents are limited to safe values normally and during single
fault conditions.
Patient is protected against electrosurgical burns at the electrodes.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 17


Function Description Gamma / Gamma XL Patient Monitor

Defibrillation protection does not drain excessive current away from the
patient.
Specially shielded connectors and cables are used to provide excellent
immunity up to 1000MHz and can not be touched by the patient even
when disconnected.
Single cable from MultiMed Pod to main Gamma / Gamma XL Monitor
unit reduces clutter between bed and monitor.

Figure 2 Front End


Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04
All rights reserved. Copyright reserved.

5 Physiological Transducers gather physiological data at the patient and feed them into the
Parameter Data small MultiMed Pod at the bed. The MultiMed Pod in turn is connected via a
Acquisition 3-meter cable to the front end in the main unit where analog ECG, Respira-
tion, Temperature, and SpO2 signals are converted to digital form and sent
through isolators for processing.

5.1 ECG/Resp The MultiMed Pod located close to the patient accepts a set of 3, 5 or 6
shielded ECG electrode leads, an SpO2 (Nellcor) cable adapter, and a tem-
perature sensor. The ECG section contains RF filters, and overvoltage
clamps that include 1k series resistors to limit shunting of defibrillator current.
The SpO2 and temperature sections also contain RF filters. Impedance respi-

18 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

ration is sensed through the ECG electodes. Void-free potting and internal
shielding enable compact containment of high voltage defibrillator and elec-
trosurgery pulses. The small interconnecting cable to the main assembly is
captive at the MultiMed POD but plugs into the MultiMed front end via a spe-
cially shielded connector.

The front end accepts physiological signals from the MultiMed POD connec-
tor and feeds temperature, respiration, and ECG signals via RF filters, config-
uration multiplexers, and pre-amplifiers to a high-speed multiplexer driving a
16-bit analog-to-digital (A/D) converter. The data stream is sent to the Main
Processor board via an opto-isolator. Control commands from the Processor
are sent out to the front end on a similar isolating link. Isolated DC power is
also provided.

The ECG signals are conductively coupled to the isolated circuits via current-
limiting series resistors, whereas the SpO2 signals are optically isolated at
the transducer. Temperature signals are doubly insulated at the patient by
disposable boots on the sensors. AC (40kHz) excitation currents for respira-
tion monitoring are dc-isolated by high-voltage ceramic capacitors.

The A/D samples the following parameters:

Table 1 Parameter Sampling Table

Parameter # of Channels
ECG 4
Pace 2
SpO2 Red 1
SpO2 IR 1
NBP 1
Resp 1
Temp 2

The hardware pace detector monitors the ECG signal in two of the four chan-
nels (those not connected to the chest leads). All other signals are decimated
and filtered using digital signal processing in the MPC823E. High oversam-
pling rate is required to minimize the requirements (and size) of the analog
anti alias filters. Superior rejection to ESU and other types of interference is
achieved with this type of design.

5.1.1 ECG Bandwidth is set flexibly by software filters.


Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

Reconfigurable neutral selector can drive any electrode.


All rights reserved. Copyright reserved.

Lead-on detection functions with even poor electrodes.


Calibration voltages can be superimposed on patient wave-forms or onto
flat baselines.

See Figure 3. Composite electrocardiographic (ECG) signals generated by


the heart and by a pacemaker are filtered to reduce RF interference from
impedance respiration and electrosurgery and then injected with dc lead-off
detection currents. Over-voltage clamps protect the semiconductors from the
surges passing the spark gaps in the MultiMed Pod and also reduce the dc
current applied to the patient due to a component fault.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 19


Function Description Gamma / Gamma XL Patient Monitor

Figure 3 Lead-Forming Network

5.1.2 Lead Selection A lead-forming network following the RF filter generates the necessary refer-
ence points for electrocardiographic measurements. Both normal leads (I, II,
III, V1 and V2) and augmented leads (aVL, avR, and avF) can be obtained.
Four differential channels generate the main axes I, II, V1 and V2. The
remaining leads are derived mathematically as indicated in the vector dia-
gram of Figure 3.

5.1.3 Lead-Off Detection Lead-off detection is accomplished by introducing a very small current into
each patient electrode, which would drive the corresponding input high if it
were disconnected. A set of five comparators detects a lead-off condition.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

5.1.4 Low-Pass Filtering and The ECG preamplifier has a flat frequency response of 0.5 - 40Hz, with a
Common Mode software notch filter at 50/60 Hz. A 180 combined signal drives the neutral
All rights reserved. Copyright reserved.

Enhancement electrode to increase the CMMR.

5.2 Respiration Impedance respiration is monitored by injecting a 40 kHz square wave of cur-
rent into the RA electrode. The resulting 40 kHz voltage drop between the RA
+ LL electrodes is proportional to the impedance. Especially balanced true
current sources do not load the ECG electrodes or distort the ECG morphol-
ogy. The returning 40 kHz differential voltage is amplified, synchronously
demodulated, and low-pass filtered. An AC-coupled stage with an autobloc
DC restorer feeds the input to the A/D converter with a nominal output of 60
mV per Ohm.

20 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

5.3 SpO2

Figure 4 SpO2 Functional Block Diagram

The pulse oximeter circuit uses a Nellcor sensor to detect the oxygen satu-
ration level in arterial blood flow. Determination of the concentration of oxy-
gen in the blood is based upon the principle that the absorption of red (R)
light depends on the degree of oxygenation of the blood, whereas the absorp-
tion of infrared (IR) radiation is relatively independent of oxygenation and
causes only constant attenuation. See Figure 4. In the SpO2 sensor, R and
IR light emitting diodes (LEDs) are alternately pulsed ON at a 25% duty cycle.
The light is transmitted through a well-perfused part of the body, such as a
fingertip or an ear lobe. The intensity of light (including ambient) transmitted
through or scattered by the blood is converted to a current by a photodiode in
the sensor. The current that appears when both LEDs are OFF depends
mainly on the ambient light, which is later subtracted to leave only the R or IR
signal levels. The large dynamic range of the light intensities requires con-
stant automatic monitoring and adjustment.

The intensities of the R and IR sources are independently controlled by two


digital-to-analog converters (DACs) attenuating the 2.5 V reference. These
levels or zero are sequentially selected by a multiplexer, and converted to a
driving current which is further guided or inverted by an output multiplexer to
the LEDs in the sensor.

5.3.1 SpO2 Front End The primary purpose of the SpO2 front end is to convert the sensors analog
signal into individual digitized signals for the red and infrared analog signals
for processing by the microprocessor. See Figure 5. Circuitry in the front end
first eliminates the non-pulsatile component in the input signal, then demulti-
plexes the resulting pulsatile signal to separate the R and IR signal compo-
nents, and finally converts the demultiplexed R and IR analog signals into
serial digital data streams.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 21


Function Description Gamma / Gamma XL Patient Monitor

Figure 5 Sensor LED Timing Diagram

A sequence of light pulses, driven from the chopped current source in the
sensor LEDs, are passed through a finger or an earlobe to a photodiode. The
sensor LEDs are connected in an anti-parallel fashion on one pair of wires. A
timing generator controls the sensor LEDs and signal multiplexing/ demulti-
plexing (see Figure 5) by means of three control signals:
IRONL (infrared LED)
AMBONL (LEDS not lit)
REDONL (red LED)

5.3.2 Input Stage A preamplifier converts the photocurrent to an equivalent voltage, and applies
it to a 20 Hz high-pass filter that removes the non-pulsatile component. The
output of the preamplifier is fed to a saturation detector.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

5.3.3 Brightness Control If the output of the preamplifier is in saturation, the gate array provides a sig-
nal to the digital-to-analog converters (DACs), which controls the drive cur-
All rights reserved. Copyright reserved.

rent to increase or decrease the brightness of the LEDs.

Controlling LED brightness extends the system dynamic range. For a very
transparent subject it may not be possible to reduce the gain to prevent satu-
ration. In that event, the brightness must be reduced. An additional purpose is
to equalize the received amplitude of each wavelength. If both LEDs are
turned ON to maximum brightness, and the software finds an extraordinary
difference between the two, the microprocessor tends to reduce that differ-
ence by equalizing the R or IR brightness signals.

22 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

5.3.4 Ambient Light Rejection The ambient rejection amplifier is a synchronous detector. The signal applied
Amplifier to its inverting input is a composite of R, IR, and ambient signals. The non-
inverting input is the same signal gated by the timing generator. This synchro-
nously multiplexes the IR, ambient, and R analog signals.

5.4 Invasive Blood Pres-


sure

Figure 6 IBP Functional Block Diagram

The IBP circuit has been designed to be used with a strain gauge pressure
transducer. See Figure 6. The analog portion of the IBP circuit provides exci-
tation voltages for resistance bridge transducers. These voltages are derived
from a reference which is also used to derive the A/D converter reference
voltage. At the circuit input, a resistor divider network provides for transducer
unplugged detection. R-C filtering and protection diodes limit the effects pro-
duced during electrosurgery, defibrillation, and other such procedures. A
selector multiplexer allows for the insertion of calibration signals into the
amplifier stage. The multiplexor feeds the pressure signal to a buffer ampli-
fier, which in turn feeds the AD converter analog input. This allows the moni-
tor to measure pressure signals in a range greater than 700 mmHg with a
resolution of approximately .02mmHg/LSB.

When no pressure transducer is plugged into the monitor, the resistor divider
network puts a negative signal into the instrumentation amplifier, which prop-
agates through the system to indicate the unplugged condition.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 23


Function Description Gamma / Gamma XL Patient Monitor

5.5 Non-Invasive Blood


Pressure

Figure 7 NBP Functional Block Diagram

5.5.1 NBP Subsystem The NBP subsystem consists of the following components:
pump
two modulating valves
strain-gauge pressure transducer
overpressure sensor
pneumatic manifold

In addition, an electronic data acquisition and control system measures and


digitizes the pressure pulses as the cuff inflates and deflates. Pump and
valve control circuitry engage these elements as needed in the measurement
cycle. Several interlock systems and expiration timers ensure the safety of
the equipment in case of single point failures.

The Gamma / Gamma XL Monitor NBP circuit uses a cuff and the oscillomet-
ric method to determine blood pressure without using a microphone. A strain-
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

gauge pressure transducer is DC-coupled to a 16-bit A/D converter, so that


cuff pressure is measured with adequate resolution to detect blood pressure
All rights reserved. Copyright reserved.

pulses. This eliminates the need for a separate ac-coupled measurement


channel, with its associated distortion and long transient recovery.

5.5.2 NBP System Description The combination of high-resolution A/D conversion and digital filtering,
together with wide-range linear deflation control allows the circuit to measure
blood pressure very rapidly and accurately, and to recover quickly from
motion artifacts. The non-invasive pressure system is composed of the fol-
lowing components:
pneumatic assembly

24 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

electronic circuitry, mounted on the Main CPU Board

Pneumatic Assembly The pneumatic assembly contains a pump, two modulating valves (V1 and
V2), two air filters (intake and manifold), and a manifold assembly which inter-
connects these components. The pump provides the pressurized air to inflate
the blood pressure cuff. V1 and V2 control the air flow during the deflation
phase of a blood pressure measurement. V1 is a normally-closed exhaust
valve with a relatively small orifice (relative to V2). V2 is a normally-open
exhaust valve with a relatively large orifice. The pump speed can be con-
trolled to permit accurate inflation pressures for special applications. The fil-
ters prevent potential contamination of pneumatic components by debris
coming from the cuff or hose.

Electronic Circuitry The electronic circuitry, mounted on the Main CPU Board, contains the elec-
trical drivers for the pump, the valves, and its power supplies. In addition, the
readback from the pressure transducer is processed through the floating sec-
tion ADC. The software data acquisition and algorithm processing is per-
formed in the MPC823E main processor.

5.5.3 Operation The measurement sequence consists of an inflation phase, in which the air
pump inflates the cuff, which has been wrapped around the patients limb
(typically the upper arm or thigh) to a predetermined pressure. At this point,
the blood circulation to the limb is occluded. The monitor then linearly
deflates the cuff at a software-controlled rate during which time the blood
pressure parameters are determined by digital filtering and analysis of wave-
form data obtained from the pressure transducer during the deflation cycle.

Inflation Phase When a blood pressure measurement is initiated (via software or front panel
fixed key), V2 closes, the pump turns ON, and the pressure transducers mon-
itor the ensuing pressure rise. When the pressure has reached the target
inflation pressure, the pump turns OFF and a dynamic braking circuit rapidly
brings the pump to a halt. The target inflation pressure adapts to the patients
systolic pressure, just occluding the blood flow. The software monitors the
slope of the pressure curve during inflation to estimate the cuff volume, a fac-
tor used in the deflation sequence.

Deflation Phase After the pump stops, there is a short delay to allow thermal transients to set-
tle. Either V1 or V2 is modulated to control the deflation rate. The choice of
V1 or V2 and the initial pulse width is made based on the estimated cuff vol-
ume determined during the inflation cycle. The chosen valve is modulated at
a 20 Hz rate, and the pulse width (open time) is continuously adjusted to pro-
vide a linear deflation rate. If initial deflation was started with V1, the software
may determine that it needs to switch to V2 to maintain proper deflation. In
either case, V2 opens fully (de-energizes) when the measurement cycle is
ended to allow for rapid and complete deflation.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

5.5.4 NBP Hardware Pump control circuitry provides the following three functions:
limits the current to the pump when it starts, to prevent power supply
All rights reserved. Copyright reserved.

overload
dynamically brakes the pump when the pump is shut off
provides a closed-loop speed control for special low-flow operations

Speed Control Pump speed is controlled by measuring the back-EMF generated by the
motor winding, which is directly proportional to the speed. However, to obtain
a measurement of the back-EMF, the drop caused by copper losses must be
added to the voltage appearing on the motor winding. The speed control
effectively drives the pump at constant full speed.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 25


Function Description Gamma / Gamma XL Patient Monitor

Current Limit Dedicated circuitry limits the current to the pump. When the current on the
pump is approx. 363 mA, the current loop takes over and limits its value. The
microprocessor and an N-channel FET turn the pump ON.

5.5.5 Valve Control A relatively high pulse voltage is used to drive V1 and V2 to get quick
response and extend the pulse-width flow control range.

5.5.6 Power Supplies Separate control logic supplies voltage (+12V) to the pump and V2 to provide
them with redundant turn-off capability. Without +12V the pump cannot run,
and V2 can neither close nor remain closed. Power supplies necessary for
operation of the NBP circuitry are derived as follows:

+5V and -5V Supply The +5V and -5V for the NBP analog circuitry are derived from the floating
section.

+12V Supply The +12V drives the NBP pump and both modulating valves. The Gamma /
Gamma XL Monitor flyback supply produces the +12V. This circuit produces
several voltages needed for monitor operation. The main flyback regulation
loop is closed around the +12V output, therefore making it the best regulated
of the multiple voltages generated.

In operation, a resistor network samples the +12V output and feeds it into the
controller chip error amplifier, which compares it to an internal reference. The
duty cycle of the switching transistor is adjusted to null this reference. A sep-
arate current feedback loop is used to stabilize the circuit and provide current
limiting protection.

+36V Regulator A +36V supply used to accelerate the energizing of the valve coils is derived
from the 42V raw supply generated by the flyback supply.

5.5.7 Power Supply Monitor The power supply monitor circuit provides reset logic to the microprocessor,
and the redundant power switch circuit, both at power-up and in the event of
a power failure or voltage drop. The heart of the monitor is a power supervi-
sor chip. At power-up, the control line is held low for a period of about 200
ms, after which the voltage rises to the +5V level. After start-up, any dip in the
+5V that causes the output to go to less than +4.75V causes the same
sequence. A resistor network is used to monitor the +12V supply. When the
voltage on the reference signal falls below +1.25V, a reset sequence similar
to the one described above ensues. The +5V and -5V are monitored via the
floating section ADC.

5.5.8 Safety Timer The safety timer becomes active only after starting the pump at least one
time. Once the pump has been activated, the timer circuit operates regard-
less of whether the pump has been turned off. Starting of the pump is sensed
by voltage developed across the pump sense resistor. If as a result of some
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

failure, hardware or software, the pump continues to run longer than the timer
expiration period, a microcontroller output rises and opens a redundant
All rights reserved. Copyright reserved.

switch, which causes the pump to turn off and V2 to open.

The safety timer period is derived from the microcontroller clock. Note that,
for redundancy purposes, the safety timer is implemented not in the
MPC823E but in the 68HC912D60A microcontroller.

Among other signals multiplexed into the floating section data stream are
power supply monitor voltages. Measuring these voltages gives an indication
of the integrity of the power supplies and the A/D converter voltage reference.

26 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

5.5.9 Pressure Channels Pressure fluctuations in the cuff change the balance of the pressure mea-
surement bridge, resulting in a differential voltage which is fed into an ampli-
fier. The gain of the amplifier is determined by the setting of a calibration
potentiometer. This potentiometer is initially adjusted in the factory, and from
then on the calibration should be checked every year.

The overpressure hardware is fed by a single power source. This increases


safety of the system, since a failure of the reference voltages does not impact
operation of the overpressure channel. An overpressure test is performed at
each power-up cycle to ensure that the overpressure circuitry is working. Any
error detected in the overpressure comparator circuit is fed to the redundant
power switch circuitry described above. The software overpressure detection
is completely independent of the overpressure circuitry.

5.6 Temperature Circuit

Figure 8 Temperature Functional Block Diagram

Temperature measurements are made using a thermistor probe that is electri-


cally equivalent to YSI 400 series probes. See Figure 8.

5.6.1 Reference Networks Two independent reference networks are used to verify correct circuit func-
tion by measuring the difference between the reference network ratio values
(simulating -5C and +50C temperatures), and reporting an error if that dif-
ference exceeds the expected range of values. The reference networks are
also used to cancel offset and gain errors in the measure-ment circuits. The
measurements of the two references allows for the determination of circuit
offset and gain within the accuracy of the reference networks.

5.6.2 A/D Converter A resistor network linearizes the voltage versus temperature curve of the
thermistor to within 2C. Later the curve is further linearized to 0.01C, using
a look-up table in the microprocessor. The maximum power to the thermistor
element is limited to 50 W. To maintain high accuracy, all signal voltages are
ratiometric to the A/D converter voltage reference. The sensitive electronics
are protected from damage by an RF filter and an overvoltage clamp.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

A multiplexer selects one of three inputs: T1, T-5, or T50. T-5 and T50 are
All rights reserved. Copyright reserved.

used in a two-point error correction algorithm, to measure the actual gain and
offset of the measurement circuit. The T-5 and T50 voltages are created by
precision resistor dividers, and are calculated to simulate the voltage that
would appear at T1 when a thermistor probe is at a temperature of -5C and
50C, respectively.

When a thermistor probe is disconnected from the measurement circuit, the


voltage at the input to the A/D converter reaches a value that is above posi-
tive full scale. The microprocessor is programmed to interpret a positive full
scale value from the A/D converter as a probe disconnect.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 27


Function Description Gamma / Gamma XL Patient Monitor

6 etCO2 Pod

Figure 9 etCO2 Sensing Process Functional Block Diagram

The etCO2 pod non-invasively monitors end-tidal CO2 using a technique that
relies on the selective absorption properties of the CO2 to specific frequen-
cies of infra-red radiation. See Figure 9 .

In the sensor a thick film infra-red source is pulsed at a rate of approximately


87 Hz, generating a broad- band spectrum of IR. Selective filtering separates
this into two narrow regions, one inside and one outside the band of CO2
absorption. The detector associated with the filter outside the band of CO2
absorption records the maximum level of the source energy since the signal it
receives is not affected by CO2. It provides a baseline which serves as a Ref-
erence for the level of CO2 in the airway.

The other detector senses a filtered energy level modified by the presence of
CO2. As the level of CO2 increases, the CO2 gas molecules in the airway
absorb more of the light energy and less signal reaches the detector. This
signal, converted by the detector, is referred to as the Data signal. Current
through the thick-film source is bidirectional to offset the tendency of particles
within the source to migrate when exposed to a strong unidirectional electric
field caused by current flow only in one direction. This keeps the structure of
the source uniform and enhances system integrity and life of the product.

To acquire a precise level of CO2, both channels are simultaneously sampled


and the level of CO2 is determined from the ratio of the Data and the Refer-
ence channels. The ratio is compared to a look-up table in memory to estab-
lish the correct value in units of mmHg.
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

The pod then sends the results to the PodCom input of the Gamma /
All rights reserved. Copyright reserved.

Gamma XL Monitor for further processing and display.

28 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Function Description

7 Power Supply Sys-


tem

Figure 10 Power System Block Diagram

The monitor can be powered from any of several sources --


A lead-acid or lithium-ion battery, housed in the monitor
A CPS (Communication/Power Supply), through a docking station,
An IDS (Infinity Docking Station)
An AC power adapter

As illustrated in Figure 10, the ac power adapter and the IDS are connected
in parallel. The monitor is normally powered by an IDS, in a pick-and-go
application, and by the ac power adapter in a stand-alone application. If both
supplies were to be connected simultaneously the one with a higher voltage
would take over.

Two solid state switches, the eliminator switch and the battery switch, govern
supply of power to the monitor and charging of the battery. In addition, there
are three DC/DC converters, two buck regulators that produce the main +5V
and +3.3V, and a multi-output flyback supply that generates three auxiliary
voltages, including the voltage that is used to charge the battery.

On/Off logic circuitry manages the condition of the switches and the DC/DC
converters under different circumstances, and responds to the On/Off push-
button on the monitor front panel. The logic is implemented in the microcon-
troller.

7.1 Main Battery A lead-acid main battery should sustain autonomous operation of the monitor
Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04

for approximately 75 minutes. A lithium-ion main battery should sustain


autonomous operation of the monitor for approximately 180 minutes. When
All rights reserved. Copyright reserved.

the battery eliminator is connected, power to the load and charging power for
the battery is provided from the AC mains.

To be fully charged, lead-acid batteries require a voltage of approximately


2.45 V/cell at 25C (14.7 V in Gamma / Gamma XL Monitors). This voltage
should not be sustained after full charge has been reached, however,
because the battery starts to outgas which reduces its life. Therefore, voltage
to the battery must be reduced to 2.30 V/cell at 25C. This is known as the
float voltage. At this voltage the battery can remain indefinitely connected to
the monitor, ready to deliver current when necessary. The charging circuitry in

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 29


Function Description Gamma / Gamma XL Patient Monitor

the Gamma / Gamma XL Monitor automatically varies the charging cycle.


Lithium-ion batteries require a constant charging voltage. See Section 3.5
Battery Control and ON/OFF Control above.

7.2 AC Power Adapter The ac power adapter is a regulated 12V (nominal) supply with enough cur-
rent capability to supply the load and charge the battery at the same time.
The eliminator switch (see Figure 10) is turned ON when the input voltage
exceeds 11.25 V, allowing the ac power adapter to feed the rest of the moni-
tor circuitry. The battery is charged from the output of the flyback supply
through a regulating FET and a low-value sense resistor.

Gamma_Gamma_XL_SM_Function_Description.fm 03.12.04
All rights reserved. Copyright reserved.

30 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Maintenance Procedures

31
32
Gamma / Gamma XL Patient Monitor Maintenance Procedures

Maintenance Procedures

1 Maintenance Proce-
dure

1.1 General Gamma and Gamma XL Patient Monitors require replacement of the lead-
acid battery (12 months), NBP air intake filter (24 months) and fluorescent
bulb (45K - 50K hours). Replacement of the fluorescent bulb, however,
requires partial disassembly of the monitor and is therefore considered a
repair procedure. An NBP calibration check is recommended to be performed
either annually or in accordance with local regulations.

1.2 Battery To obtain maximum life from a new lead-acid battery, install the battery into
the monitor and run the monitor on battery power for a period of 15 minutes.
After the 15 minute period, either plug in the monitors power adapter or lock
the monitor onto a powered docking station and charge the battery, or
remove the battery from the monitor and connect the battery to an external
charger. (This initial sequence is not needed for Li batteries.)

Note

When in storage or not in use for an extended period of time, lead-acid bat-
teries self-discharge and develop a float-charge as a characteristic of the
self-discharge process. The float charge must be drained off before the
battery can be properly charged. If a new battery is immediately placed on
a charger, the float charge provides an incorrect indication of the batterys
charge condition, and the charger may not fully charge the battery.

Between discharges, the lead-acid battery must be recharged as soon as


possible. Once charged, it can be stored for several months without recharg-
ing. Starting at a 100% charge level, at room temperature the battery self-dis-
charges below the acceptable minimum in 6 months on a shelf and in 2
months in an unpowered spare monitor. Drger Medical recommends that the
battery charge be maintained at >80% to maximize the batterys capacity and
cycle life.

Warning

Dispose of used batteries in accordance with local regulations gov-


erning disposal of hazardous materials.

1.3 Replacing NBP Air There are two NBP air filters: an air intake filter and a manifold filter. The air
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

Intake Filter
All rights reserved. Copyright reserved.

intake filter is accessible from the top of the battery compartment and is
replaced periodically (every 24 months). The manifold filter is located in the
manifold subassembly itself and rarely requires replacement. Replacement of
the manifold filter is considered a repair procedure rather than a maintenance
procedure.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 33


Maintenance Procedures Gamma / Gamma XL Patient Monitor

Figure 1 Location of NBP Air Intake Filter in Battery Compartment

1. Open battery compartment door and remove battery.


2. Remove plastic cap covering air intake filter through opening in top of bat-
tery compartment. (See arrow in Figure 1.)
3. Withdraw filter from filter housing using needle-nose pliers.
4. Fully insert new filter into filter housing, with open end of filter facing
inward, and replace cap.

Note

NBP filters have an opening in one end. The end with the opening must be
inserted into the filter housing for the filter to function properly.

5. Reinstall battery and battery compartment door.

1.4 Safety and Function Drger Medical recommends that a full functional verification be performed
Tests annually. Also, some national jurisdictions require that a temperature calibra-
tion check and an NBP calibration be performed at least every two years.
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

Refer to appropriate Fault and Cause Tables if the monitor should fail any cal-
ibration check or functional verification procedure that cannot be rectified by
simple adjustment. Document test results on a copy of the Acceptance Test
Report (see Section 1.5 Acceptance Test Report.

1.4.1 Power Circuits and Star- The following procedures check the monitors power circuits, power-up
tup sequence, and power-off indicator. Begin this procedure with monitor turned
off, main battery removed, and ac power adapter disconnected.

34 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

AC Power Adapter 1. With power cord connected to a hospital-grade power source, plug ac
power adapter into monitor.
2. Verify that green Battery Charger LED on front panel of monitor illumi-
nates.

Power-Up Sequence 3. Press ON/OFF switch on front panel, and verify following sequence of
events.
a) Power ON LED in ON/OFF key turns on, display illuminates and mon-
itor emits a brief tone.
b) Startup screen containing displays character changing colors as it
descends towards Drger Medical Logo.
c) Monitor emits a brief tone and screen goes blank for a few seconds.
d) Pressure relief valve pulses.
e) Display reappears containing copyright notice, installed software ver-
sion, and message Loading software, please wait....
f) MAIN screen replaces Startup Screen after several seconds.

Power Off Indicator 4. Press ON/OFF switch, and verify that monitor powers-down and a high
pitched tone sounds for 7 seconds.
5. Disconnect external power source from monitor, and verify that Battery
Charger LED turns off.

Battery and Charging Cir- 6. Install main battery.


cuit

Note

Battery should have at least 50% charge level, as indicated by the charge
level bar graph in the display message area.

7. Press ON/OFF switch on front panel, and verify the following:


Monitor powers-up according to normal power-up sequence of
events. (Refer to power-up sequence in step 3.)
Battery charge level indicator appears in message field on bottom left
hand side of display.
8. Plug in ac power adapter, and verify that the Green Battery Charger LED
on front panel of monitor illuminates, screen brightness increases, and
after 14 seconds, charge level indicator disappears.

1.4.2 Optical Encoder The Rotary Knob on the front panel controls an optical encoder for pointing to
and selecting fields and functions on the display.
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

1. After power-up sequence has completed, press Rotary Knob and verify
that fill color of New Patient NO prompt changes to white indicating that
you can now confirm value NO or change it to YES.
2. Turn knob one notch (detent, click) in either direction, and verify that
value in NO field changes to YES. Turn knob another notch, and verify
that value changes back to NO.
3. Choose YES, and verify that New Patient prompt disappears.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 35


Maintenance Procedures Gamma / Gamma XL Patient Monitor

1.4.3 TFT-LCD Display The Gamma Patient Monitor display is composed of an active-matrix, 6.5
inch TFT-LCD screen with backlite. The Gamma XL Patient Monitor display is
composed of an active-matrix, 8.4 inch TFT-LCD screen with backlite. Test
the TFT-LCD display as follows:

1. Verify that backlite provides sufficient and consistent background illumi-


nation for TFT-LCD.
2. Verify that there are 17 inoperative pixels (stuck ON or OFF).

1.4.4 Fixed Keys The following tests verify that membrane switches on the front panel are func-
tioning properly, and that the signal from the key is processed by the Front
Panel Control PCB.

Note

Before beginning Key tests access Main menu. Select Monitor Setup
Monitor Options Speaker Volumes, and assure that Attention Tone Vol-
ume is set to other than OFF.

ON/OFF Key The ON/OFF key initiates the power-on sequence if the monitor is powered
off, and powers-off the monitor, initiating a brief power-off piezo alarm, if the
monitor is powered-on.

Note

This test can be omitted if the procedure in step 3 of Section 1.4.1 Power
Circuits and Startup has already been performed.

1. Press and momentarily hold ON/OFF key.


2. Verify that powered state of monitor changes from ON to OFF or from
OFF to ON.
3. Set monitor to powered-on state, if monitor powered off.

Main Screen and Menu The Main Screen key sets the display to the MAIN screen.
Keys 4. Press Menu key to display Main menu.
5. Press Main Screen key, and verify that Main menu extinguishes, and dis-
play returns to MAIN screen.

Alarm Silence Key The Alarm Silence key silences an alarm tone for one minute.
6. Assure that HR alarm is enabled, and without any input applied to Mul-
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

tiMed POD, plug MultiMed or MultiMed 6 cable into monitor. Monitor


should Alarm.
7. Press Alarm Silence key and verify that alarm ceases.

Alarm Limits Key The Alarm Limits fixed key calls up a setup table on which upper and lower
alarm limits for physiologic parameters can be assigned, and alarms and
alarm recordings can be enabled or disabled.
8. Attach patient simulator to MultiMed cable and set simulator as follows:
ECG = Normal Sinus
HR = 60 beats per minute (bpm)

36 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

9. With MAIN screen displayed, press Alarm Limits fixed key.


10. Verify that Alarms Setup Table displays.
11. Set Upper HR alarm parameter to 55.

All Alarms Off Key The All Alarms Off key silences all alarms for a period of 3 minutes.
12. When alarm sounds (setup in previous step), press All Alarms Off key.
13. Verify message All Alarms Off appears on display.
14. Verify that after 3 minutes, alarm sounds and All Alarms Off message
disappears.
15. Set alarm parameter within alarm condition (60).

Record Key The Record key initiates a recording when monitor is connected, either
directly or via a network, to an R50 Recorder and otherwise initiates a stored
recording.
16. Press Record key.
17. Verify Recording Started appears in message field.

NBP Start/Stop Key The NBP Start/Stop key initiates or terminates the inflation cycle for the non-
invasive blood pressure monitor function.
18. Press Menu key. Access Monitor Setup Monitor Options Speaker
Volume Medium.
19. Press NBP Start/Stop key.
20. Verify that monitor sounds a tone. (Cuff must Not be plugged into cuff
connector.)

Fast Access Key The Fast Access key allows access to the monitors bottom channel menu as
well as tabular trends, graphical trends and Event recall screen.
21. Press Fast Access key, Access Bottom Channel, then select All.
22. Verify that parameter boxes appear across bottom of display.
23. Access Bottom Channel NBP.
24. Verify NBP parameter boxes across bottom of display.
25. Access Bottom Channel Waveform.
26. Verify that 4th channel waveform is displayed.

Note:

A 4th display channel is standard in Gamma XL monitors, and available as


a option for Gamma monitors.

27. Access Trend graphs, then press rotary knob.


Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

28. Verify that Trend Tables appear on display.


29. Access Trend Tables, then press rotary knob.
30. Verify that Trend Tables appear on display.
31. Access Event Recall, then press rotary knob.
32. Verify that Event Recall screen appears on display.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 37


Maintenance Procedures Gamma / Gamma XL Patient Monitor

1.4.5 ECG/RESP 1. Connect either a 3-lead, 5-lead, or 6-lead ECG cable from the Patient
Simulator into the MultiMed POD.

ECG/RESP Test Setup 2. Select HR parameter box and press rotary knob in to bring up ECG
menu.
3. Set all ECG Lead settings at default values and remaining parameters as
follows:
Tone Source ECG
Tone Volume Low
Pacer Detection On
QRS Marks On
ECG Processing ECG1
ECG Leads (set for type cable installed in step 1)
Arrhythmia On
Relearn depress knob to update Arrhythmia
4. Set simulator as follows:
ECG = Normal Sinus
HR = 80 beats per minute (bpm)
amplitude = 1.0 mV
RESPIRATION = Normal Rest.
rate = 20 breaths per minute (BPM)
ohms = 1.0
LEAD SELECT = II/RL-LL
BASELINE IMPEDANCE = 500

Waveforms/Digital Read- 5. Verify the following:


outs/Tones Waveform and HR correspond to data provided by simulator.
Heart symbol blinks and pulse tone sounds for each QRS complex.
White spike present at each QRS complex.
RESP and HR digital readout correspond to settings of simulator.
6. Vary Tone Volume setting and verify that pulse tone volume changes.
7. Set Tone Volume to OFF, and verify that pulse tone stops.

Lead-Off Indicators 8. One at a time, disconnect each ECG lead from simulator.
9. Verify Lead-Off message appears in message area, pulse tone ceases,
and *** replaces digital heart rate in HR field for each lead removed in
step 8.
10. Reconnect all leads to simulator.
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

Alarm Function This procedure also tests that the alarm function of the monitor, as applicable
All rights reserved. Copyright reserved.

to all other patient parameters, is operational in the monitor.


11. In Alarm Limits Table, set HR alarm parameters as follows:
Upper limit = 110 bpm
Lower limit = 40 bpm
Alarm = ON
12. Set simulator to HR = 120 bpm.
13. Verify that monitor responds with following Serious Alarm indications:
HR in parameter field = 120

38 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

HR parameter field blinks and color changes.


Serious Alarm tone sounds.
Message HR > 110 appears in message area at bottom of display.
14. Reset simulator to HR = 80 bpm.Verify the following:
HR parameter field returns to normal color
HR returns to 80
Message area continues to report cause of most recent alarm
15. Press Alarm Silence fixed key.
16. Verify that HR > 110 ceases to be reported.

1.4.6 Asystole 1. Switch power to simulator OFF. Verify that HR parameter field reports
ASY, Asystole appears in message area at bottom of display, and moni-
tor responds with Life-Threatening alarm.
2. Switch power to simulator ON.

1.4.7 SpO2 The Gamma Monitor reports oxygen saturation (SpO2) and pulse rate using
the spectrophotometric method. SpO2 software is checked on monitor power-
up and also periodically while the monitor is in operation.

SpO2 Test Setup 1. Select SpO2 parameter box to access menu. Set parameters as follows:
Pulse Tone Source SpO2
Pulse Tone Volume Low
Bargraph ON
Averaging Normal
2. On Main Screen, highlight Channel 2 field and access menu. Set param-
eters as follows:
Curve SpO2
Size 20-30%
3. Apply SpO2 sensor to finger.
4. Verify an SpO2 reading of 94 in the monitors SpO2 parameter box.
(Allow approx. 20 seconds for reading to stabilize.)

Waveforms/Digital Read- 5. Verify the following:


outs/Tones Channel 2 displays SpO2 waveform, and digital SpO2 and pulse rate
(PLS) values.
Pulse strength bar graph pulses SpO2 in field, symbol blinks in PLS
field, and pulse tone sounds for every detected pulse.

1.4.8 Temperature Using the Temperature Y-Cable input to the MultiMed Pod, set up the patient
simulator to supply a temperature input.
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

Functional Verification Pro- 1. Set the simulator for a standard 37C.


cedure 2. Verify that monitor indicates temperature of 37 0.1C.
3. Change simulator to temperature above and then below 37C.
4. Verify that monitor readout agrees with simulator settings 0.1C.Perform
Temperature Calibration Check, if required by local Regulatory Stan-
dards.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 39


Maintenance Procedures Gamma / Gamma XL Patient Monitor

1.4.9 Temperature Calibration In some national jurisdictions temperature calibration must be checked peri-
Check odically as specified in the Operating Instructions or User Guide (at least
every two years). Use the following procedure.

Recommended Equipment Decade Resistor with 0.1% accuracy (or fixed resistors with same accu-
racy)
Temp Adapter Cable, Art. No. 51 98 333 E530U (Optional)

Procedure 1. Connect MultiMed pod to input of patient monitor.


2. Connect temp adapter cable to MultiMed Pod (if needed).
3. Connect temperature input to decade resistor.

Table 1 Resistance Value vs. Temperature

Resistance Set Tempera- Monitor Tolerance Pass


Setting () ture Reading
6990 1.0 0.9 to 1.1
3539 15.0 14.9 to 15.1
1355 37.0 36.9 to 37.1
843.2 49.0 48.9 to 49.1

4. For each resistance value in Table 1, verify that monitor reports Set Tem-
perature value 0.1C.
5. Document test results on a copy of Acceptance Test Report.

1.4.10 etCO2 (if installed) The etCO2 Pod enables the Gamma/Gamma XL Monitor to non-invasively
monitor end-tidal CO2 (etCO2) using a technique that relies on the selective
absorption properties of CO2 to specific frequencies of infrared radiation. The
pod automatically compensates for variations in ambient barometric pressure
if set to automatic mode. Before beginning this procedure, use a mercury col-
umn barometer or equivalent other device to determine local atmospheric
pressure. Record this value_________.

1. Press Main screen key.


2. Click on etCO2 parameter box.
3. Click on etCO2 source.
4. Select POD nd click knob.
5. Press Main Screen key.
6. Connect Sensor (without adapter) to etCO2 pod and pod to monitor.
(Observe etCO2 Sensor Warming Up in message field at top of display.)
7. After etCO2 Sensor Warming Up disappears (approximately 2 minutes),
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

select etCO2 parameter box and in etCO2 setup menu select More.
8. Select Atm Press Mode - Manual.
9. Select Atm Pressure and set value as recorded above.
10. Press Main Screen key.
11. Select etCO2 parameter box and in etCO2 Setup menu, select Sensor
Cal.
12. After etCO2 Place Sensor On Zero Cell appears at top of display, place
sensor on Zero Cell.

40 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

13. Verify etCO2 Calibrating Sensor appears in message field, followed by


etCO2 Place Sensor on Ref Cell.
14. After etCO2 Place Sensor on Ref Cell appears, place sensor on Refer-
ence Cell.
15. Verify that etCO2 Verifying Sensor Cal, appears, then etCO2 Sensor
Cal Verified appears simultaneously with a tone.
16. Verify reading in etCO2 parameter box = 38 2mmHg.Remove reference
cell, insert adaptor into sensor and press Main Screen key.
17. For adapter calibration, refer to corresponding Users Guide.

Note:

Refer to SCIO Service Manual for SCIO tests.

1.4.11 Non-Invasive Blood


Pressure

Figure 2 Test Setup

System Setup and Pneu- Set up NBP Calibration assembly (28 77 855) as illustrated in Figure 2.
matics Leakage Test Assure that pneumatic leakage is within specifications before continuing to
Functional and Calibration Check.

1. Power-up monitor.
2. After MAIN screen displays on monitor, double-click rotary knob to accept
New Patient.
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

3. Turn rotary knob until NBP field is highlighted, then depress knob.
4. Set following in NBP parameter field menu:
Interval Mode: OFF
Calibration Mode: ON (Observe NBP Cuff 0 mmHg appears in lower
right area of NBP field
Inflation Mode: Adult: 270

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 41


Maintenance Procedures Gamma / Gamma XL Patient Monitor

5. Clamp pneumatic hose (with hemostat or clamp) between T-connector


and monitor (1 in Figure 2) and using pressure bulb, increase pressure to
250 5 mmHg. Then clamp hose at inflation bulb (2 in Figure 2), and let
pressure stabilize for 1 minute. Do NOT run pump.
6. Observe pressure drop for an additional 5 minutes. Drop should be
<2 mmHg in 5 minutes. If not, tighten all connections and fittings and
retest equipment for leakage. When leakage test OK, go on to step 7.
7. With both clamps removed, reinflate to 250 5 mmHg, if necessary, and
then re-clamp hose at inflation bulb.
8. Observe pressure drop for 1 minute. Drop should be <4 mmHg.
If leakage test OK, remove clamp at inflation bulb and go on to Func-
tional and Calibration Check.
If leakage test not OK, monitors internal pneumatics system needs to
be serviced. Contact your Draegermedical Service Product Repre-
sentative.

Functional and Calibration 1. Using hand bulb, increase pressure to 250 5 mmHg, if necessary, and
Check allow it to stabilize for 1 minute.
2. Verify that pressure values displayed on monitor (lower left message
area) and pressure indicator are within 3 mmHg of each other.
3. Slowly release pressure in decrements of 50 mmHg. At pressures of 200,
150, 100, and 50 mmHg, verify that pressure values on monitor and pres-
sure indicator are within 3 mmHg of each other at each level.
4. If NBP function fails calibration check, contact your Draegermedical Ser-
vice Product Representative. Otherwise, if NBP function is OK, Set Cali-
bration Mode to OFF as described in steps 3 and 4 of System Setup
Procedure above, and continue.
5. Document test results on a copy of Acceptance Test Report.

1.4.12 Invasive Blood Pressure

Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

Figure 3 IBP Test Setup

IBP Test Setup 1. Connect simulator BP output to IBP input on monitors left side panel,
using adapter cable 33 68 383.
2. On MAIN Screen, select Channel 2 waveform field, and select following
on Channel 2 menu.
Waveform - GP1
Size - 200 mmHg

42 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

3. Return to MAIN Screen.

Calibration 4. Apply a static pressure of 0 mmHg from patient simulator.


5. Select pressure parameter box.
6. Select Zero in IBP Setup window.
7. Verify that GP1 Zero Accepted exhibits in message field, and that a flat
pressure curve is displayed at 0 line in second waveform channel.
8. Change static pressure to 100 mmHg at patient simulator.
9. Select Manometer Cal. in IBP Setup window.
10. Set Manometer Cal. to 100. (Even if Manometer Cal. reads 100, select
field and reset value to 100.)
11. Verify that GP1 Cal. Accepted exhibits in message field simultaneously
with a tone. Return to MAIN screen.
12. Verify that Mean, Diastolic and Systolic values displayed read 100 mmHg
2 mmHg, and that a flat pressure curve is displayed exactly in the mid-
dle of waveform channel.
13. Increase static pressure to 200 mmHg.
14. Verify that Mean, Diastolic and Systolic values displayed are 200 mmHg
2 mmHg, and that flat pressure curve is displayed in waveform channel.

IBP Limits Alarms 15. In Alarm Limits Table select AutoSet.


16. In Alarm Limits Table set Syst/Dia/Med Alarm to ON.
17. Set simulator to stat < 50.
18. Verify that monitor responds with following Serious Alarm indications:
Mean, Diastolic and Systolic values = simulator stat setting.
GP1 parameter field changes to yellow.
Serious Alarm tone sounds.
Messages GP1 Static, GP1 Dia <170 and GP1 Mean <170blink
on and off in message field.
19. In Alarm Limits Table set Sys/Dia/Med Alarm to OFF.

1.4.13 Leakage Current Test Gamma and Gamma XL Patient Monitors are battery operated devices, iso-
lated from ground by the transformer in an ac power adapter, or grounded
through the IDS power supply when operated from an external ac power
source. Leakage current tests assure that under both normal and fault condi-
tions, any leakage current does not exceed values given in Table 2. Use the
following general procedure to measure leakage currents.

Table 2 Leakage Current Tests

TEST Max. Current


Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

Combined Lead Leakage <10A


Individual Lead Leakage <10A
Paired Lead Leakage <10A
Leakage with Line Voltage on Leads <50A

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 43


Maintenance Procedures Gamma / Gamma XL Patient Monitor

1. Perform leakage current tests on a Gamma series monitor with ac power


adapter (see Figure 4) or IDS power supply (see Figure 5) plugged into
leakage tester.Attach MutiMed cable (1 in Figure 4 and in Figure 5) to
Monitor.Attach MutiMed cable ECG leads (2 in Figure 4 and in Figure 5)
to corresponding posts at Leakage Tester.

Figure 4 Block Diagram: Earth Leakage Current (AC/DC Power Adapter)

Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

Figure 5 Block Diagram: Earth Leakage Current (Infinity Docking Station)

2. Follow leakage tester manufacturers instructions to measure each leak-


age current given in Table 2, for each of following conditions:

44 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Maintenance Procedures

Combined Lead Leakage


Individual Lead Leakage
Paired Lead Leakage
Leakage with Line Voltage on Leads
3. Verify that current does not exceed values shown in Table 2.
4. Document test results on a copy of Acceptance Test Report.Disconnect
MutiMed cable ECG leads (2 in Figure 4 and in Figure 5) from corre-
sponding posts at Leakage Tester.Short together all leads to shield at end
of PodCom Leakage Test Cable (4 in Figure 4 and in Figure 5) and con-
nect leads and shield to RL post of Leakage Tester.Attach Pod Com
Leakage Test Cable (3 in Figure 4 and in Figure 5) to Gamma PodPort
connector.Follow leakage tester manufacturers instructions to measure
each leakage current given in Table 2, for each of following conditions:
Individual Lead Leakage
Leakage with Line Voltage on Leads
5. Verify that current does not exceed values shown in Table 2.
6. Document test results on a copy of Acceptance Test Report.

1.5 Acceptance Test Site: ______________________________ Date: ____________


Report
Technician: ___________________________

Location: ___________________________

Monitor Serial Number: ___________

Installed SW Version: ________

= Function OK

Power Circuits and Startup_____

Optical Encoder_____

TFT-LCD Display_____

Fixed Keys _____

ECG/Resp _____

Asystole_____
Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04

All rights reserved. Copyright reserved.

SpO2 _____

Temperature_____

Functional Verification_____

Calibration check (if required)_____

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 45


Maintenance Procedures Gamma / Gamma XL Patient Monitor

Resistance Set Tempera- Monitor Tolerance Pass


Setting () ture Reading

6990 1.0 0.9 to 1.1

3539 15.0 14.9 to 15.1

1355 37.0 36.9 to 37.1

843.2 49.0 48.9 to 49.1

etCO2 (if installed)_____

Non-Invasive Blood Pressure _____

Invasive Blood Pressure_____

Leakage Current Test_____


Combined Lead leakage (A)_______
Individual Lead leakage (A)_______
Paired Lead leakage (A)_______
Leakage with Line Voltage on Leads (A)_______

Monitor has passed all required tests.

_____________________________________ ________________

Servicing Technician Date

Gamma_Gamma_XL_SM_Maintenance.fm 03.12.04
All rights reserved. Copyright reserved.

46 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Schematics and Diagrams

47
48
Gamma / Gamma XL Patient Monitor Schematics and Diagrams

Schematics and Dia-


grams

1 IBP Connector

Figure 1 IBP Connector (refer to Table 1)

Table 1 IBP Connector Pinouts

Pin No. Signal Pin No. Signal

1 +VREF 2 -VREF

5 +IBP 6 -IBP

3, 4, 7 GND 8, 9 SHIELD

2 MultiMed Pod Con-


nector

Figure 2 MultiMed Pod Connector (refer to Table 2)

Table 2 MultiMed Pod Connector Pinouts

Temp SPO2 ECG


Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04

Pin No. Signal Pin No. Signal Pin No. Signal Pin.No. Signal

1 TA 1 DETA 1 SHGND 2 LA
All rights reserved. Copyright reserved.

2 TB (Not Used) 2 DETK SH 3 SHGND 4 LL

3 TCOM 3 NC 5 SHGND 6 RA

4 NC 4 REDK 7 SHGND 8 V

5 NC 5 RCALRTN 9 SHGND 10 RL

6 NC 6 RCALIB

7 NC 7 IRK

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 49


Schematics and Diagrams Gamma / Gamma XL Patient Monitor

3 Docking Station
Connector

Figure 3 Docking Station Connector (refer to Table 3)

Table 3 Docking Station Connector Pinouts

Pin No. Signal Pin No. Signal

1 RCDRPWR 15 DUTX2

2 DCGND 16 DURX2

3 PTXD3 17 DCGND

4 PRXD3 18 VGARED

5 DCGND 19 VGAGRN

6 EXTAUD 20 VGABLU

7 ALARM 21 DCGND

8 PSNL 22 VSYNCLB

9 DUTX1 23 HSYNCLB

10 DURX1 24 RCV-

11 DCGND 25 RCV+

12 DSPWR 26 TX-

13 DURTS 227 TX+

14 DUCTS2 28 SW6

4 Alarm Cable (Unter-


minated)
Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04
All rights reserved. Copyright reserved.

Figure 4 SHP ACC CBL ALARM UNTERM 5M (refer to Table 4)

Table 4 Remote Alarm Cable Color Code

Connector Pin No. Relay Input Wire Color SPDT Relay Output Circuit Status

1 Tan Brown RTN

2-8 NC Green Inactive Open

50 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Schematics and Diagrams

Connector Pin No. Relay Input Wire Color SPDT Relay Output Circuit Status

9 Orange White Inactive Closed

10 - 14 NC

5 Interface Plate Con-


nector

Figure 5 Interface Plate Connector (refer to Table 5)

Table 5 Interface Plate Connectors Pinouts

Pin No CRT - X5 Recorder/Alarm - X7

1 Ext Red GND

2 VGND +12VDC

3 Ext Grn Rec Tx

4 VGND +12VDC

5 Ext Blu Diag Tx

6 VGND +12VDC

7 GND Rec RTS

8 H Sync Rec CTS

9 V Sync Alarm Out

10 Rem TxD Rec GND

11 Rem RxD Rec GND

12 Power Switch Rec Rx

13 Rem Audio Rec GND

14 Rem Audio Ret Diag Rx


Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04

6 Recorder/Alarm Y-
All rights reserved. Copyright reserved.

cable

Figure 6 SHP ACC CBL Y RECORDER/ALARM (refer to Table 6)

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 51


Schematics and Diagrams Gamma / Gamma XL Patient Monitor

Table 6 Remote Alarm Cable Color Code

Connector Pin No. Relay Input Wire Color SPDT Relay Output Circuit Status

1 Tan Brown RTN

2-8 NC Green Inactive Open

9 Orange White Inactive Closed

10 - 14 NC

7 Infinity Docking Sta-


tion Connectors

Figure 7 Infinity Docking Station Connectors (refer to Table 7)

Table 7 Infinity Docking Station Connectors

ALM/KB/DIAG/COMM ALM/KB/DIAG/COMM External CRT (X5) AUX/MIB/CAN- Recorder (X13)


-1 (X4) -2 (X3) BUS(X12)

Pin Signal Pin Signal Pin Signal Pin Signal Pin Signal

1 GND 1 GND 1 Ext Red 1 MIB1 D+ 1 R50A TxD

2 Tx Data KB 2 Tx Data KB 2 VGND 2 MIB1 Pwr 2 AUX Pwr2

3 Rem Kbd Pwr 3 Rem Kbd Pwr 3 Ext Grn 3 MIB1 D- 3 R50A RxD

4 ISD Power 4 ISD PWR 4 VGND 4 MIB2 Pwr 4 AUX Pwr2

5 Diag TxD (CPS) 5 Diag TxD 5 Ext Blu 5 MIB1 S+ 5 R50A CTS

6 DEBUG1 6 MCBOOTL 6 VGND 6 CAN+ 6 AUX Pwr2

7 ISD GND 7 ISD GND 7 GND 7 MIB1 S- 7 R50A RTS


Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04

8 RxData KB 8 RxData KB 8 H-Sync 8 CAN RL 8 AUX Pwr2

9 Alarm Out 9 Alarm Out 9 V-Sync 9 AUX1 ID0 9


All rights reserved. Copyright reserved.

10 GND 10 GND 10 Remote TxD 10 AUX1 ID1 10 AUX Pwr2

11 HWBootL 11 NMI 11 Remote RxD 11 AUX1 ID2 11 AUX2 ID0

12 COMM-1 Rx 12 COMM-2 Rx 12 Pwr Switch 12 MIB2 D+ 12 AUX2 ID1

13 COMM-1 Tx 13 COMM-2 Tx 13 Rem Audio 13 GND 13 AUX2 ID2

14 Diag RxD 14 Diag RxD 14 Rem Aud 14 MIB2 D- 14 AUX2 P


Ret Enb

52 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Schematics and Diagrams

ALM/KB/DIAG/COMM ALM/KB/DIAG/COMM External CRT (X5) AUX/MIB/CAN- Recorder (X13)


-1 (X4) -2 (X3) BUS(X12)

15 GND 15 P GND

16 MIB2 S+ 16 R100A
TxD+

PSL (X20) Network (X14) 17 GND 17 P GND

Pin Signal Pin Signal 18 MIB2 S- 18 R100A


TxD-

1 GND 1 Tx+ 19 CANBUS+ 19 P GND

2 PWR 2 Tx- 20 Chassis 20 R100A


GND RxD+

3 Rx+ 21 P GND

6 Rx- 22 R100 RxD-

23 P GND

24

25 Chassis
GND

26 Chassis
GND

8 PodPort Connector
Pins

Figure 8 PodPort Connector Pins

Table 8 PodPort Connector Pinouts


Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04

Pin No. Signal


All rights reserved. Copyright reserved.

1 TXDATA+

2 NC

3 TXDATA-

4 RXDATA+

5 POD GND

6 POD PWR

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 53


Schematics and Diagrams Gamma / Gamma XL Patient Monitor

Pin No. Signal

7 RXDATA-

8,9 POD1 SHD

Gamma_Gamma_XL_SM_Schematics_and_Diagrams.fm 03.12.04
All rights reserved. Copyright reserved.

54 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Fault-Cause-Remedy

55
56
Gamma / Gamma XL Patient Monitor Fault_Cause_Remedy

Fault-Cause-Remedy

1 Troubleshooting If the Monitor should fail to respond properly to procedures prescribed in the
User Guide for the installed software version, use the procedures below to
aid in identifying and remedying the problem.

1.1 Power Problems

1.1.1 No Response When There are several possible reasons why a Monitor might not respond when
POWER ON/OFF Key the Power ON/OFF key is pressed. Required troubleshooting procedures
Pressed depend on power sources connected to the monitor. Refer to Table 1.

Table 1 Power-On Problems

Conditions Possible Cause(s) Troubleshooting and Remedial Action


Monitor connected Power Adapter malfunction 1. Assure Power Adapter is connected to an active
directly to Power hospital power source.
Adapter; Battery Monitor Malfunction 2. Disconnect power adapter from Monitor and mea-
Charger LED not illu- sure Power Adapter output voltage.
minated*
If voltage = 11.6 to 13.8 VDC, continue to step 3.
If voltage < 11.6 VDC or > 13.8 VDC, replace
Power Adapter and recheck Battery Charger
LED. If problem persists, continue to step 3.
3. Contact your Drger Medical service representative.

Monitor on docking IDS Power Supply malfunc- 1. Check for a or b below.


station; Battery charger tion a) If IDS, assure that IDS power supply is con-
LED not illuminated nected to active hospital power source.
CPS/IDS malfunction
b) If CPS, assure that CPS is connected to active
Monitor malfunction hospital power source and switched ON.
2. If CPS or IDS power supply LED not illuminated,
check power source and power cable. If O.K.,
replace CPS or IDS power supply, and recheck CPS
or IDS power supply LED. If condition persists, con-
tinue to step 3.
3. Measure voltage between pins 11 and 12 at docking
connector on docking station. (See figure inset at left
for pin locations on docking connector.)
If voltage = 11.6 to 13.8 VDC, continue to step 4.
If voltage 11.6 VDC or 13.8 VDC, replace IDS
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

Power Supply or CPS. If problem persists, con-


tinue to step 4
All rights reserved. Copyright reserved.

4. Contact your Drger Medical service representative.


Monitor on docking Corrupted Software 1. Press Power On key to power monitor ON.
station or directly con- 2. Try booting with monitor software PCMCIA card
nected to Power Front Bezel malfunction inserted into card slot.
Adapter; Battery
charger LED illumi- Front Panel PCB malfunction 3. Contact your Drger Medical service representative.
nated
Main Processor malfunction

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 57


Fault_Cause_Remedy Gamma / Gamma XL Patient Monitor

Conditions Possible Cause(s) Troubleshooting and Remedial Action


NO power. Monitor not Battery discharged or needs 1. Connect monitor to AC Power Adapter or Docking
connected to AC to be replaced Station.
Power Adapter or 2. When Battery charger LED illuminates, press
docking station; battery Battery charger circuitry mal- POWER ON/OFF key to power monitor ON and
installed function access MAIN screen. (If Battery charger LED fails to
illuminate, refer to section above on Condition -
Monitor connected directly to Power Adapter; Bat-
tery Charger LED not illuminated or Monitor on
docking station; Battery charger LED not illumi-
nated.)
3. Allow monitor or remain on Power Adapter or pow-
ered Docking Station for 1 hr. Disconnect monitor
from Power Adapter or powered Docking Station.
After 30 sec. check battery level bar graph, located
at bottom left side of display, and verify that a portion
of the bar graph is green.
If a portion of the bar graph is green, reconnect
monitor to Power Adapter or powered Docking
Station. Leave monitor connected an additional
4.5 hrs for Lead-acid type battery or 7 hrs for an
optional Lithium-ion type battery, then go to step
4.
If no portion of the bar graph is green, replace
main battery, and then repeat step 3. If charge
level remains constant, go to step 5.
4. After charging the Main battery (4.5 hrs for Lead-
acid type battery or 7 hrs for optional Lithium-ion
type battery) recheck battery charge level.
5. If charge level = 100%, return monitor to clinical ser-
vice.
6. If charge level <100% replace Main battery.
7. If problem persists with new main battery, contact
your Drger Medical service representative.

1.1.2 Power On/Off Piezo Tone Table 2 Power-off Alarm Malfunction


Fails to Sound

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


Piezo tone fails to Front Panel PCB malfunction 1. Contact your Drger Medical service representative.
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

sound when monitor


powered on, if monitor Main Processor malfunction
All rights reserved. Copyright reserved.

loses power, or when


monitor powered-off.

58 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Fault_Cause_Remedy

1.1.3 Power-up Sequence Table 3 Power-up Process Malfunction


Fails To complete Prop-
erly

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


Power inputs all OK but Software program corrupted If power ON LED illuminates but monitor fails to complete
monitor fails to com- power-up sequence, reinstall software as follows:
plete power-up Main PCB malfunction
sequence 1. With monitor powered off, insert PCMICA card into
slot at right side of monitor.
2. Power monitor on.
3. If problem persists, contact your Drger Medical ser-
vice representative.

1.2 Optical Encoder Mal- Table 4 Rotary Knob Malfunction


function

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


Rotary knob fails to Front Panel PC Board mal- Contact your Drger Medical service representative.
properly select fields, or function
pressing the knob in fails
to activate a menu or Optical Encoder malfunc-
select a default. tion

Main Processor malfunc-


tion

1.3 TFT-LCD Display Table 5 LCD Display Malfunction


Malfunction

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


>17 inoperative pixels LCD screen malfunction Contact your Drger Medical service representative.
(stuck ON or OFF).
Areas of display missing Front Panel PC Board Contact your Drger Medical service representative.
or color contaminated malfunction

Processor on Main PCB


malfunction
Backlight fails to provide TFT-LCD Display mal- Contact your Drger Medical service representative.
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

sufficient and consistent function


background illumination
All rights reserved. Copyright reserved.

for the LCD display. Inverter malfunction

Front Panel PC Board


malfunction

Main Processor malfunc-


tion

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 59


Fault_Cause_Remedy Gamma / Gamma XL Patient Monitor

1.4 Fixed Key Fails to Table 6 Fixed Key Malfunction


Function

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


A Fixed Key fails to ini- Front Bezel malfunction Contact your Drger Medical service representative.
tiate change
Front Panel PC Board mal-
function

Main Processor malfunc-


tion

1.5 Visual or Audible Table 7 Alarm Malfunctions


Alarm Reporting
Failure

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


Audible Alarm O.K., Software problem 1. Try reinstalling software.
but Visual Alarm Fails. 2. If problem persists, contact your Drger Medical service
representative.
Visual Alarm O.K., but Speaker malfunction 1. Power-cycle monitor and listen for tone after icon
Audible Alarm Fails. appears on power-up screen (not the piezo, which
Front Panel PC Board sounds before the icon appears).
malfunction 2. If tone fails to sound, replace speaker.

Main Processor malfunc- 3. If problem persists, contact your Drger Medical service
tion representative.

1.6 NBP Malfunction Table 8 NBP Malfunctions

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


NBP fails to zero prop- NBP pneumatic system Contact your Drger Medical service representative.
erly, fails characteriza- malfunction
tion, or fails calibration
check Main Processor malfunc-
tion
NBP pump fails to Front Bezel malfunction 1. If monitor reporting NBP in fault mode, or error message
start/stop when NBP displays, power-cycle monitor.
key on front panel is Front Panel PC Board 2. If problem persists, contact your Drger Medical service
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

pressed malfunction representative.

NBP pump subassembly


All rights reserved. Copyright reserved.

malfunction

Main Processor malfunc-


tion

60 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Fault_Cause_Remedy

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


NBP pump starts, but Cuff assembly malfunc- 1. Recheck cuff assembly and installation, and replace cuff
cuff fails to inflate tion assembly if defective.
/ deflate properly 2. If problem persists, check NBP tubing in rear housing of
NBP pneumatic system monitor.
malfunction
3. If tubing OK, contact your Drger Medical service repre-
sentative.

1.7 etCO2 Malfunction Table 9 etCO2 Malfunctions

Symptom(s) Possible Cause(s) Troubleshooting and Remedial Action


Parameter box fails to Sensor or cable malfunc- 1. Replace etCO2 Sensor.
appear when sensor tion 2. If problem persists, replace etCO2 Pod.
plugged into pod
etCO2 Pod malfunction 3. If problem persists, contact your Drger Medical service
representative.
PodPort PC Board mal-
Sensor fails calibra- function
tion
Main Processor malfunc-
tion
Persistent Adapter Airway adapter or sensor 1. If adapter or sensor window occluded, clean window.If
Failure message window occluded problem persists, replace airway adapter.If problem per-
sists, replace sensor.If problem persists, replace etCO2
Airway adapter malfunc- Pod.If problem persists, contact your Drger Medical ser-
tion vice representative.

Sensor malfunction
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 61


Fault_Cause_Remedy Gamma / Gamma XL Patient Monitor

1.8 No Printout from Table 10 Recorder Problems


Recorder

Symptoms Possible Cause(s) Troubleshooting and Remedial Action


Recorder Power LED Recorder malfunction 1. Assure that all units in the power chain are properly con-
NOT illuminated nected and powered ON.
when Record key Cabling malfunction 2. If problem persists do either a or b. Refer to illustrations
depressed below left.
Interface Plate (if
installed) malfunction a) If Recorder has installed Interface Plate, detach Inter-
face Plate from Recorder, depress Record key at mon-
CPS / IDS (if installed) itor and check voltage between pins 1 and 2 on
malfunction Interface Plate docking connector.
b) If Recorder mounted on Auxiliary Docking Station,
Main Processor malfunc- depress Record key and check voltage between pins 1
tion and 2 on Auxiliary Docking Station connector.
3. If voltage O.K., replace Recorder.
4. If voltage NOT O.K., check for +12VDC between pins 1
and 2 on monitor docking connector.
If voltage O.K., check for +12VDC between pins 1 and
2 of all docking connectors in path between monitor
and recorder, and between pins 2 and 15 of X13 on
CPS or IDS. Replace component that fails to provide
12VDC at the appropriate pins.
If voltage not O.K. on monitor docking connector, con-
tinue.
5. If problem persists, replace Recorder.
6. If problem persists, contact your Drger Medical service
representative.

Local Recorder con- Recorder malfunction 1. With an ECG waveform from patient simulator on Monitor
nected directly to display, press Record key.
Monitor in standal- Interconnecting cable or 2. If Recording Started followed by double-tone, then
one configuration connection malfunction Recording Stored message appears in the message
field, continue to step 2.
Recorder or Monitor Inter-
face Plate malfunction 3. If no message or recording appears, go to step 5.
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

4. If problem persists, and Recorder Cable Art. No. 43 18


Main Processor PCB mal- 130 E530U is installed, replace Recorder cable.
All rights reserved. Copyright reserved.

function 5. If problem persists, and separate Interface Plates and


Recorder cable are installed, replace each item one at a
time to isolate possible malfunction.
6. If problem persists, replace Recorder.
7. If problem persists, contact your Drger Medical service
representative.

62 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Fault_Cause_Remedy

Symptoms Possible Cause(s) Troubleshooting and Remedial Action


Local Recorder con- Recorder malfunction 1. With an ECG waveform from patient simulator on Monitor
nected to Monitor display, press Record key.
through CPS or IDS CPS/IDS - Recorder 2. If Recording Started followed by double-tone, then
cable malfunction Recording Stored message appears in the message
field, check cables and connections between Monitor,
Recorder Interface Plate CPS/IDS, and Recorder, then continue to step 5.
malfunction
3. If no message or recording appears, go to step 4.
CPS or IDS malfunction 4. Substitute Recorder connection by installing Recorder
cable, 47 21 770 or 43 13 560, in place of Docking Station,
Docking Station or CPS CPS/IDS, and cabling.
Bridge Plate malfunction 5. If problem persists, replace Recorder.

Main Processor malfunc- 6. If problem disappears, replace each component bypassed


tion by Recorder cable, to isolate source of problem and
replace malfunctioning component.
7. If problem persists, contact your Drger Medical service
representative.

1.9 Isolating Cable Mal- A general troubleshooting and repair approach for cable malfunctions is to
functions use a known input signal for any given parameter, and then replace a cable or
sensor found to be malfunctioning. Cable malfunctions, including those asso-
ciated with connectors on the cables, fall into one of three categories -- Open
circuits, Short circuits, and Intermittent conditions

Open circuits and short circuits manifest themselves as a loss of signal. Soft-
ware in the Monitor senses the loss, and generates an error message such
as ECG Leads Off and SpO2 Transparent. Typically, short circuits result in
software resets.

An intermittent condition (e.g. ECG lead not making good skin contact) may
manifest itself as noise displayed at the monitor screen. A source of ECG
noise can often be isolated by removing the signal and shorting all ECG leads
together. Then flex along the cable, particularly at connectors, while watching
for noise indications on the monitor display.

1.10 Patient-Related Data Contact your Drger Medical service representative.


Not Retained or
Monitor Fails to
Compute Trends
Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04

All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 63


Fault_Cause_Remedy Gamma / Gamma XL Patient Monitor

Gamma_Gamma_XL_SM_Fault_Cause_Remedy.fm 03.12.04
All rights reserved. Copyright reserved.

64 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Annex

Spare parts list

Test List

Problem Report

65
66
Gamma and Gamma XL Patient Monitors Spare Parts List

1 Spare Parts List

Table 1 Gamma and Gamma XL - Replaceable Parts and Subassem-


blies

Part Description Part No.


Language Label GAMMA XL DA 8in MS13768

Language Label GAMMA XL DE 8in MS13769

Language Label GAMMA XL EN 8in MS13770

Language Label GAMMA XL ES 8in MS13777

Language Label GAMMA XL FR 8in MS13771

Language Label GAMMA XL IT 8in MS13772

Language Label GAMMA XL NL 8in MS13773

Language Label GAMMA XL NO 8in MS13774

(English Label Pictured) Language Label GAMMA XL PO 8in MS13775

Language Label GAMMA XL RU 8in MS13776

Language Label GAMMA XL SV 8in MS13778

Language Label GAMMA XL TR 8in MS13779


Language Label GAMMA DA 6in MS14496

Language Label GAMMA DE 6in MS14497

Language Label GAMMA EN 6in MS14498

Language Label GAMMA ES 6in MS14509

Language Label GAMMA FR 6in MS14499

Language Label GAMMA IT 6in MS14500

Language Label GAMMA JA 6in MS14501

Language Label GAMMA NL 6in MS14502


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04

Language Label GAMMA NO 6in MS14503


All rights reserved. Copyright reserved.

(English Label Pictured)

Language Label GAMMA PO 6in MS14504

Language Label GAMMA RU 6in MS14505

Language Label GAMMA SV 6in MS14506

Language Label GAMMA TR 6in MS14507

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 1


Spare Parts List Gamma and Gamma XL Patient Monitors

Part Description Part No.

Bezel Lens GAMMA XL 8in MS13758

Bezel Lens GAMMA 6in MS14510

Optical Encoder 4311622

Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04

Rotary Knob DELTA GAMMA XL MS13765


All rights reserved. Copyright reserved.

2 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma and Gamma XL Patient Monitors Spare Parts List

Part Description Part No.

LCD SC 6802XL 8.4in 7870780

Display LCD SC 6002XL 6.5in 5950790

Backlight GAMMA XL 7869444

Backlight SC 6002XL 6.5in 7258945


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04

All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 3


Spare Parts List Gamma and Gamma XL Patient Monitors

Part Description Part No.

Board Front Pnl GAMMA XL A200 MS13757

Board DCAC CONV SC 6802XL 7869329

Board Inverter SC 6002XL 5950808

Board PodCom SC 6002XL A140 5741959


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04
All rights reserved. Copyright reserved.

4 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma and Gamma XL Patient Monitors Spare Parts List

Part Description Part No.

Intermediate Wall GAMMA XL MS13766

Int Wall GAMMA (for GAMMA w/o MS14511


podport)

Speaker SC 6002XL 5947218

PCB Processor SC 6X02XL A104 MS14350


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04

Manifold NP SC 6002XL 5950782


All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 5


Spare Parts List Gamma and Gamma XL Patient Monitors

Part Description Part No.

NBP Filter (Pkg of 10) 2866726

Panel Right GAMMA XL MS13762

Panel Left GAMMA XL MS13761

Button ram card DELTA GAMMA MS13760


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04
All rights reserved. Copyright reserved.

Handle GAMMA XL MS13767

6 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma and Gamma XL Patient Monitors Spare Parts List

Part Description Part No.

Cbl Harness Battery GAMMA/XL MS14575

Battery Latch SC 5/600XX 3379943

Lead-Acid Battery 5947697

Lithium-Ion Battery 5732354


Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04

Battery Cover GAMMA XL MS13759


All rights reserved. Copyright reserved.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 7


Spare Parts List Gamma and Gamma XL Patient Monitors

Part Description Part No.

Rear Chassis GAMMA XL MS13764

Plate Retainer GAMMA XL MS13763

Funnel SC 6002XL 5741033

Not Pictured Foot Pads (Pkg of 12) 4311374

Gamma_Gamma_XL_IEC_Spare_Parts_List.fm 03.12.04
All rights reserved. Copyright reserved.

8 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

Test List

1 Functional Verifica- Complete the following Functional Verification Tests. Document test results
tion Tests on a copy of the Test List Report.

1.1 Power Circuits and The following procedures check the monitors power circuits, power-up
Startup sequence, and power off indicator. Begin this procedure with monitor turned
off, main battery removed, and ac power adapter disconnected.

AC Power Adapter 1. With power cord connected to a hospital-grade power source, plug ac
power adapter into monitor.
2. Verify that green Battery Charger LED on front panel of monitor illumi-
nates.

Power-Up Sequence 3. Press ON/OFF switch on front panel, and verify following sequence of
events:
a) Power ON LED in ON/OFF key turns on, display illuminates and mon-
itor emits a brief tone.
b) Startup screen containing displays character changing colors as it
descends towards Drger Medical Logo.
c) Monitor emits a brief tone and screen goes blank for a few seconds.
d) Pressure relief valve pulses.
e) Display reappears containing copyright notice, installed software ver-
sion, and message Loading software, please wait....
f) MAIN screen replaces Startup Screen after several seconds.

Power Off Indicator 4. Press ON/OFF switch, and verify that monitor powers-down and a high
pitched tone sounds for 7 seconds.
5. Disconnect external power source from monitor, and verify that Battery
Charger LED turns off.

Battery and Charging Cir- 6. Install main battery.


cuit

Note

Battery should have at least 50% charge level, as indicated by the charge
level bar graph in the display message area.
7. Press ON/OFF switch on front panel, and verify the following:
Monitor powers-up according to normal power-up sequence of
events. (Refer to power-up sequence in step 3.)
Battery charge level indicator appears in message field on bottom left
hand side of display.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

8. Plug in ac power adapter, and verify that the Green Battery Charger LED
on front panel of monitor illuminates, screen brightness increases, and
after 14 seconds, charge level indicator disappears.

1.2 Optical Encoder The Rotary Knob on the front panel controls an optical encoder for pointing to
and selecting fields and functions on the display.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 1


Test List Gamma / Gamma XL Patient Monitor

1. After power-up sequence has completed, press Rotary Knob and verify
that fill color of New Patient NO prompt changes to white indicating that
you can now confirm value NO or change it to YES.
2. Turn knob one notch (detent, click) in either direction, and verify that
value in NO field changes to YES. Turn knob another notch, and verify
that value changes back to NO.
3. Choose YES, and verify that New Patient prompt disappears.

1.3 TFT-LCD Display The Gamma Patient Monitor display is composed of an active-matrix, 6.5
inch TFT-LCD screen with backlite. The Gamma XL Patient Monitor display is
composed of an active-matrix, 8.3 inch TFT-LCD screen with backlite. Test
the TFT-LCD display as follows:

1. Verify that backlite provides sufficient and consistent background illumi-


nation for TFT-LCD.
2. Verify that there are 17 inoperative pixels (stuck ON or OFF).

1.4 Fixed Keys The following tests verify that membrane switches on the front panel are func-
tioning properly, and that the signal from the key is processed by the Front
Panel Control PCB.

Note

Before beginning Key tests access Main menu. Select Monitor Setup
Monitor Options Speaker Volumes, and assure that Attention Tone Vol-
ume is set to other than OFF.

ON/OFF Key The ON/OFF key initiates the power-on sequence if the monitor is powered
off, and powers-off the monitor, initiating a brief power-off piezo alarm, if the
monitor is powered-on.

Note

This test can be omitted if the procedure in step 3 of Section 1.1 Power Cir-
cuits and Startup has already been performed.

1. Press and momentarily hold ON/OFF key.


2. Verify that powered state of monitor changes from ON to OFF or from
OFF to ON.
3. Set monitor to powered-on state, if monitor powered off.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

Main Screen and Menu The Main Screen key sets the display to the MAIN screen.
All rights reserved. Copyright reserved.

Keys 4. Press Menu key to display Main menu.


5. Press Main Screen key, and verify that Main menu extinguishes, and dis-
play returns to MAIN screen.

Alarm Silence Key The Alarm Silence key silences an alarm tone for one minute.
6. Assure that HR alarm is enabled, and without any input applied to Mul-
tiMed POD, plug MultiMed or MultiMed 6 cable into monitor. Monitor
should Alarm.
7. Press Alarm Silence key and verify that alarm ceases.

2 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

Alarm Limits Key The Alarm Limits fixed key calls up a setup table on which upper and lower
alarm limits for physiologic parameters can be assigned, and alarms and
alarm recordings can be enabled or disabled.
8. Attach patient simulator to MultiMed cable and set simulator as follows:
ECG = Normal Sinus
HR = 60 beats per minute (bpm)
9. With MAIN screen displayed, press Alarm Limits fixed key.
10. Verify that Alarms Setup Table displays.
11. Set Upper HR alarm parameter to 55.

All Alarms Off Key The All Alarms Off key silences all alarms for a period of 3 minutes.
12. When alarm sounds (setup in previous step), press All Alarms Off key.
13. Verify message All Alarms Off appears on display.
14. Verify that after 3 minutes, alarm sounds and All Alarms Offmessage
disappears.
15. Set alarm parameter within alarm condition (Q 60).

Record Key The Record key initiates a recording when monitor is connected, either
directly or via a network, to an R50 Recorder and otherwise initiates a stored
recording.
16. Press Record key.
17. Verify Recording Started appears in message field.

NBP Start/Stop Key The NBP Start/Stop key initiates or terminates the inflation cycle for the non-
invasive blood pressure monitor function.
18. Press Menu key. Access Monitor Setup Monitor Options Speaker
Volume Medium.
19. Press NBP Start/Stop key.
20. Verify that monitor sounds a tone. (Cuff must Not be plugged into cuff
connector.)

Fast Access Key The Fast Access key allows access to the monitors bottom channel menu as
well as tabular trends, graphical trends and Event recall screen.
21. Press Fast Access key, Access Bottom Channel, then select All.
22. Verify that parameter boxes appear across bottom of display.
23. Access Bottom Channel NBP.
24. Verify NBP parameter boxes across bottom of display.
25. Access Bottom Channel Waveform.
26. Verify that 4th channel waveform is displayed.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

Note:

A 4th display channel is standard in Gamma XL monitors, and available as


a option for Gamma monitors.

27. Access Trend graphs, then press rotary knob.


28. Verify that Trend Tables appear on display.
29. Access Trend Tables, then press rotary knob.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 3


Test List Gamma / Gamma XL Patient Monitor

30. Verify that Trend Tables appear on display.


31. Access Event Recall, then press rotary knob.
32. Verify that Event Recall screen appears on display.

1.5 ECG/RESP 1. Connect either a 3-lead, 5-lead, or 6-lead ECG cable from the Patient
Simulator into the MultiMed POD.

ECG/RESP Test Setup 2. Select HR parameter box and press rotary knob in to bring up ECG
menu.
3. Set all ECG Lead settings at default values and remaining parameters as
follows:
Tone Source ECG
Tone Volume Low
Pacer Detection On
QRS Marks On
ECG Processing ECG1
ECG Leads (set for type cable installed in step 1)
Arrhythmia On
Relearn depress knob to update Arrhythmia
4. Set simulator as follows:
ECG = Normal Sinus
HR = 80 beats per minute (bpm)
amplitude = 1.0 mV
RESPIRATION = Normal Rest.
rate = 20 breaths per minute (BPM)
ohms = 1.0
LEAD SELECT = II/RL-LL
BASELINE IMPEDANCE = 500

Waveforms/Digital Read- 5. Verify the following:


outs/Tones Waveform and HR correspond to data provided by simulator.
Heart symbol blinks and pulse tone sounds for each QRS complex.
White spike present at each QRS complex.
RESP and HR digital readout correspond to settings of simulator.
6. Vary Tone Volume setting and verify that pulse tone volume changes.
7. Set Tone Volume to OFF, and verify that pulse tone stops.

Lead-Off Indicators 8. One at a time, disconnect each ECG lead from simulator.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

9. Verify Lead-Off message appears in message area, pulse tone ceases,


All rights reserved. Copyright reserved.

and *** replaces digital heart rate in HR field for each lead removed in
step 8.
10. Reconnect all leads to simulator.

Alarm Function This procedure also tests that the alarm function of the monitor, as applicable
to all other patient parameters, is operational in the monitor.
11. In Alarm Limits Table, set HR alarm parameters as follows:
Upper limit = 110 bpm
Lower limit = 40 bpm

4 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

Alarm = ON
12. Set simulator to HR = 120 bpm.
13. Verify that monitor responds with following Serious Alarm indications:
HR in parameter field = 120
HR parameter field blinks and color changes.
Serious Alarm tone sounds.
Message HR > 110 appears in message area at bottom of display.
14. Reset simulator to HR = 80 bpm.Verify the following:
HR parameter field returns to normal color
HR returns to 80
Message area continues to report cause of most recent alarm
15. Press Alarm Silence fixed key.
16. Verify that HR > 110 ceases to be reported.

1.6 Asystole 1. Switch power to simulator OFF. Verify that HR parameter field reports
ASY, Asystole appears in message area at bottom of display, and moni-
tor responds with Life-Threatening alarm.
2. Switch power to simulator ON.

1.7 SpO2 The Gamma Monitor reports oxygen saturation (SpO2) and pulse rate using
the spectrophotometric method. SpO2 software is checked on monitor power-
up and also periodically while the monitor is in operation.

SpO2 Test Setup 1. Select SpO2 parameter box to access menu. Set parameters as follows:
Pulse Tone Source SpO2
Pulse Tone Volume Low
Bargraph ON
Averaging Normal
2. On Main Screen, highlight Channel 2 field and access menu. Set param-
eters as follows:
Curve SpO2
Size 20-30%
3. Apply SpO2 sensor to finger.
4. Verify an SpO2 reading of 94 in the monitors SpO2 parameter box.
(Allow approx. 20 seconds for reading to stabilize.)

Waveforms/Digital Read- 5. Verify the following:


outs/Tones Channel 2 displays SpO2 waveform, and digital SpO2 and pulse rate
(PLS) values.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

Pulse strength bar graph pulses SpO2 in field, symbol blinks in PLS
field, and pulse tone sounds for every detected pulse.

1.8 Temperature Using the Temperature Y-Cable input to the MultiMed Pod, set up the patient
simulator to supply a temperature input.

1.8.1 Functional Verification 1. Set the simulator for a standard 37C.


Procedure 2. Verify that monitor indicates temperature of 37 0.1C.
3. Change simulator to temperature above and then below 37C.

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 5


Test List Gamma / Gamma XL Patient Monitor

4. Verify that monitor readout agrees with simulator settings 0.1C.Perform


Temperature Calibration Check, if required by local Regulatory Stan-
dards.

1.8.2 Temperature Calibration In some national jurisdictions temperature calibration must be checked peri-
Check odically as specified in the Operating Instructions or User Guide (at least
every two years). Use the following procedure.

Recommended Equipment Decade Resistor with 0.1% accuracy (or fixed resistors with same accu-
racy)
Temp Adapter Cable, Art. No. 51 98 333 E530U (Optional)

Procedure 1. Connect MultiMed pod to input of patient monitor.


2. Connect temp adapter cable to MultiMed Pod (if needed).
3. Connect temperature input to decade resistor.

Table 1 Resistance Value vs. Temperature

Resistance Set Tempera- Monitor Tolerance Pass


Setting () ture Reading

6990 1.0 0.9 to 1.1


3539 15.0 14.9 to 15.1
1355 37.0 36.9 to 37.1
843.2 49.0 48.9 to 49.1

4. For each resistance value in Table 1, verify that monitor reports Set Tem-
perature value 0.1C.
5. Document test results on a copy of the Test List Report.

1.9 etCO2 (if installed) The etCO2 Pod enables the Gamma/Gamma XL Monitor to non-invasively
monitor end-tidal CO2 (etCO2) using a technique that relies on the selective
absorption properties of CO2 to specific frequencies of infrared radiation. The
pod automatically compensates for variations in ambient barometric pressure
if set to automatic mode. Before beginning this procedure, use a mercury col-
umn barometer or equivalent other device to determine local atmospheric
pressure. Record this value_________.

1. Press Main screen key.


2. Click on etCO2 parameter box.
3. Click on etCO2 source.
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

4. Select POD nd click knob.


All rights reserved. Copyright reserved.

5. Press Main Screen key.


6. Connect Sensor (without adapter) to etCO2 pod and pod to monitor.
(Observe etCO2 Sensor Warming Up in message field at top of display.)
7. After etCO2 Sensor Warming Up disappears (approximately 2 minutes),
select etCO2 parameter box and in etCO2 setup menu select More.
8. Select Atm Press Mode - Manual.
9. Select Atm Pressure and set value as recorded above.
10. Press Main Screen key.

6 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

11. Select etCO2 parameter box and in etCO2 Setup menu, select Sensor
Cal.
12. After etCO2 Place Sensor On Zero Cell appears at top of display, place
sensor on Zero Cell.
13. Verify etCO2 Calibrating Sensor appears in message field, followed by
etCO2 Place Sensor on Ref Cell.
14. After etCO2 Place Sensor on Ref Cell appears, place sensor on Refer-
ence Cell.
15. Verify that etCO2 Verifying Sensor Cal, appears, then etCO2 Sensor
Cal Verified appears simultaneously with a tone.
16. Verify reading in etCO2 parameter box = 38 2mmHg.Remove reference
cell, insert adaptor into sensor and press Main Screen key.
17. For adapter calibration, refer to corresponding Users Guide.

1.10 Non-Invasive Blood


Pressure

Figure 1 Test Setup

1.10.1 System Setup and Pneu- Set up NBP Calibration assembly (Art. No. 28 77 855 EE54U) as illustrated in
matics Leakage Test Figure 1. Assure that pneumatic leakage is within specifications before con-
tinuing to Section 1.10.2 Functional and Calibration Check, Calibration
Check.

1. Power-up monitor.
2. After MAIN screen displays on monitor, double-click rotary knob to accept
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

New Patient.
3. Turn rotary knob until NBP field is highlighted, then depress knob.
4. Set following in NBP parameter field menu:
Interval Mode: OFF
Calibration Mode: ON (Observe NBP Cuff 0 mmHg appears in lower
right area of NBP field
Inflation Mode: Adult: 270

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 7


Test List Gamma / Gamma XL Patient Monitor

5. Clamp pneumatic hose (with hemostat or clamp) between T-connector


and monitor (1 in Figure 1) and using pressure bulb, increase pressure to
250 5 mmHg. Then clamp hose at inflation bulb (2 in Figure 1), and let
pressure stabilize for 1 minute. Do NOT run pump.
6. Observe pressure drop for an additional 5 minutes. Drop should be
<2 mmHg in 5 minutes. If not, tighten all connections and fittings and
retest equipment for leakage. When leakage test OK, go on to Step 7.
7. With both clamps removed, reinflate to 250 5 mmHg, if necessary, and
then re-clamp hose at inflation bulb.
8. Observe pressure drop for 1 minute. Drop should be <4 mmHg.
If leakage test OK, remove clamp at inflation bulb and go on to Func-
tional and Calibration Check.
If leakage test not OK, monitors internal pneumatics system needs to
be serviced. Contact your Draeger Medical Service Product Repre-
sentative.

1.10.2 Functional and Calibra- 1. Using hand bulb, increase pressure to 250 5 mmHg, if necessary, and
tion Check allow it to stabilize for 1 minute.
2. Verify that pressure values displayed on monitor (lower left message
area) and pressure indicator are within 3 mmHg of each other.
3. Slowly release pressure in decrements of 50 mmHg. At pressures of 200,
150, 100, and 50 mmHg, verify that pressure values on monitor and pres-
sure indicator are within 3 mmHg of each other at each level.
4. If NBP function fails calibration check, calibrate NBP system. Then return
to step 5. Otherwise, if NBP function is OK, Set Calibration Mode to
OFF as described in steps 3 and 4 of Section 1.10.1 System Setup and
Pneumatics Leakage Test and continue.
5. Document test results on a copy of Test List Report.

1.11 Invasive Blood Pres-


sure

Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04
All rights reserved. Copyright reserved.

Figure 2 IBP Test Setup

IBP Test Setup 1. Connect simulator BP output to IBP input on monitors left side panel,
using adapter cable Art. No. 33 68 383 E530U.
2. On MAIN Screen, select Channel 2 waveform field, and select following
on Channel 2 menu.
Waveform - GP1
Size - 200 mmHg

8 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

3. Return to MAIN Screen.

Calibration 4. Apply a static pressure of 0 mmHg from patient simulator.


5. Select pressure parameter box.
6. Select Zero in IBP Setup window.
7. Verify that GP1 Zero Accepted exhibits in message field, and that a flat
pressure curve is displayed at 0 line in second waveform channel.
8. Change static pressure to 100 mmHg at patient simulator.
9. Select Manometer Cal. in IBP Setup window.
10. Set Manometer Cal. to 100. (Even if Manometer Cal. reads 100, select
field and reset value to 100.)
11. Verify that GP1 Cal. Accepted exhibits in message field simultaneously
with a tone. Return to MAIN screen.
12. Verify that Mean, Diastolic and Systolic values displayed read 100 mmHg
2 mmHg, and that a flat pressure curve is displayed exactly in the mid-
dle of waveform channel.
13. Increase static pressure to 200 mmHg.
14. Verify that Mean, Diastolic and Systolic values displayed are 200 mmHg
2 mmHg, and that flat pressure curve is displayed in waveform channel.

IBP Limits Alarms 15. In Alarm Limits Table select AutoSet.


16. In Alarm Limits Table set Syst/Dia/Med Alarm to ON.
17. Set simulator to stat < 50.
18. Verify that monitor responds with following Serious Alarm indications:
Mean, Diastolic and Systolic values = simulator stat setting.
GP1 parameter field changes to yellow.
Serious Alarm tone sounds.
Messages GP1 Static, GP1 Dia <170 and GP1 Mean <170blink
on and off in message field.
19. In Alarm Limits Table set Sys/Dia/Med Alarm to OFF.

2 Leakage Current The Gamma Patient Monitor is a battery operated device, isolated from
Test ground by the transformer in an ac power adapter, or grounded through the
IDS power supply, when operated from an external ac power source. Leak-
age current tests assure that under both normal and fault conditions, any
leakage current does not exceed values given in Table 2. Use the following
general procedure to measure leakage currents.

Table 2 Leakage Current Tests

TEST Max. Current


Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

Combined Lead Leakage <10A


Individual Lead Leakage <10A
Paired Lead Leakage <10A
Leakage with Line Voltage on Leads <50A

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 9


Test List Gamma / Gamma XL Patient Monitor

1. Perform leakage current tests on a Gamma series monitor with ac power


adapter (see Figure 3) or IDS power supply (see Figure 4) plugged into
leakage tester.Attach MutiMed cable (1 in Figure 3 and in Figure 4) to
Monitor.Attach MutiMed cable ECG leads (2 in Figure 3 and in Figure 4)
to corresponding posts at Leakage Tester.

Figure 3 Block Diagram: Earth Leakage Current (AC/DC Power Adapter)

Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04
All rights reserved. Copyright reserved.

Figure 4 Block Diagram: Earth Leakage Current (Infinity Docking Station)

2. Follow leakage tester manufacturers instructions to measure each leak-


age current given in Figure 4, for each of following conditions:

10 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Test List

Combined Lead Leakage


Individual Lead Leakage
Paired Lead Leakage
Leakage with Line Voltage on Leads
3. Verify that current does not exceed values shown in Table 2.
4. Document test results on a copy of Test List Report.Disconnect MutiMed
cable ECG leads (2 in Figure 3 and in Figure 4) from corresponding posts
at Leakage Tester.Short together all leads to shield at end of PodCom
Leakage Test Cable (4 in Figure 3 and in Figure 4) and connect leads and
shield to RL post of Leakage Tester.Attach Pod Com Leakage Test Cable
(3 in Figure 3 and in Figure 4) to Gamma PodPort connector.Follow leak-
age tester manufacturers instructions to measure each leakage current
given in Figure 4 , for each of following conditions:
Individual Lead Leakage
Leakage with Line Voltage on Leads
5. Verify that current does not exceed values shown in Table 2.
6. Document test results on a copy of Test List Report.

3 Test List Report Site: ______________________________ Date: ____________

Technician: ___________________________

Location: ___________________________

Monitor Serial Number: _________

Installed SW Version: ________

File a copy of this report with site documentation.

= Function OK

Power Circuits and Startup_____

Optical Encoder_____

TFT-LCD Display_____

Fixed Keys _____

ECG/Resp _____
Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04

All rights reserved. Copyright reserved.

Asystole_____

SpO2 _____

Temperature_____

Functional Verification_____

Calibration Check (if required)_____

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 11


Test List Gamma / Gamma XL Patient Monitor

Resistance Setting () Set Temperature Monitor Reading Tolerance Pass

6990 1.0 0.9 to 1.1

3539 15.0 14.9 to 15.1

1355 37.0 36.9 to 37.1

843.2 49.0 48.9 to 49.1

etCO2 (if installed)_____

Non-Invasive Blood Pressure _____

Invasive Blood Pressure_____

Leakage Current Test_____


Combined Lead leakage (A)_______
Individual Lead leakage (A)_______
Paired Lead leakage (A)_______
Leakage with Line Voltage on Leads (A)_______

Monitor has passed all required tests.

_____________________________________ ________________

Service Technician Date

Gamma_Gamma_XL_SM_IEC_Test_List.fm 03.12.04
All rights reserved. Copyright reserved.

12 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Gamma / Gamma XL Patient Monitor Problem Report

Enter all applicable data in the spaces provided, and include a copy of this form when faxing a request for
technical assistance.

Name of contact
Telephone
Fax
Email Address (If available)
Monitoring Site: Country:
Region / State / Province:
Hospital or Clinical Site:
Device Type:
Device Serial Number:
Device Operating Software:
Care Unit Type:
Parameters being monitored at time of fault:
Network / Stand-alone Use
Brief Description of Fault:
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________
Can the problem be reproduced or is the problem intermittent?

Has a customer complaint on this product been filed?


Complaint Reference Number (If applicable)

Fax inquiry to your local Drger


Medical Service Representative:
All rights reserved. Copyright reserved.
Gamma_Gamma_XL_Problem_Report.fm 03.12.04

Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released 1


Problem Report Gamma / Gamma XL Patient Monitor

All rights reserved. Copyright reserved.


Gamma_Gamma_XL_Problem_Report.fm 03.12.04

2 Drger Medical AG & Co. KGaA 6013.053 Revision 0 Released


Drger Medical AG & Co. KGaA
Moislinger Allee 53 55
D-23542 Lbeck
Germany

Tel: (++49) (0) 1805-3723437


Fax: (++49) 451/882 - 3779

Subject to change without notice.


Will not be replaced in the event of modifications.

You might also like