Sapphire Event Viewer Software User Manual

Using the Event Viewer Software to download the Event Log from the Sapphire Infusion Pump The following explains how to download an Event Log from the Sapphire Infusion pump (including but not limited to: Sapphire Multi-Therapy Infusion Pump, Sapphire Epidural Infusion Pump, Sapphire PCA Infusion Pump or the Sapphire TPN Infusion Pump) to a computer (PC). This DFU is applicable to Event Viewer Software Rev13.

Overview The Event Viewer software allows the review of the Sapphire pump operation history (Event Log). The Sapphire pump stores up to 8,000 events in its Event Log memory and the Event Viewer software is used for downloading, sorting and filtering events by description or date.

For a complete list of the events recorded in the Event Log, refer to the Event Log Tables, starting on page 12.

• Make sure to use an Event Viewer software version that is

equivalent to or a higher than the software version of the Sapphire pump. The Event Viewer software version can be viewed by clicking the 'About' option in the 'Help' tab at the top of the Event Viewer main screen.

• The Event Viewer software can only be used with Sapphire pump Rev09 software and above.

Once an Event Log is downloaded, it can be saved in .csv format.

•

I

The .csv file may be imported as a text file by opening it in Excel® spreadsheet softwareI .

Excel is a registered trademark of Microsoft Corporation in the U.S. and/or other countries. Using the Event Viewer software to download the Event Log Infusion Pump from the Sapphire 2/24

Event Log files should be sent for evaluation at Q Core Medical Ltd. in the following circumstances:

• • • • •

The pump was involved in the injury or death of a patient. The pump was involved in an event that may have caused injury or death of a patient; or The pump has caused or may have caused injury to the medical staff; or The pump is not performing as expected. Upon Q Core Medical's request.

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System Requirements Before installing the Event Viewer software, verify that the following hardware and software requirements are met:

Minimum Hardware Requirements • • •

PC: Intel® Core™2 DuoII - 2GB RAM Screen resolution: 1280 x 1024 pixels Q Core Medical’s Communication Cable for the Sapphire pump.

• •

Distributed by Hospira Worldwide, Inc. (P/N 05020-110-0213).

RS232 connectivity, in either of the following forms:

•

A RS232 port in the PC

Or

•

Q Core Medical’s USB to 4 Port RS232 Adapter

•

Distributed by Hospira Worldwide, Inc. (P/N 15077-000-0001).

Minimum Software Requirements • • •

Operating System: Windows ® XP operating system, Windows ® III Vista operating system, or Windows ® 7 operating system (32 or 64 bit). Excel ® -spreadsheet software (2003 or later). IV

WinRAR ® shareware file archiver and data compression software or other software for handling .zip files.

II

Intel and Intel Core are trademarks of Intel Corporation in the U.S. and/or other countries III Windows is a registered trademark of Microsoft Corporation in the U.S. and/or other countries. IV WinRAR is a registered trademark of win.rar GmbH. Using the Event Viewer software to download the Event Log from the Sapphire Infusion Pump

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Installing the Event Viewer Software on your Computer > To Install the Event Viewer softwa re on your co mput er :

1.

After launching the installer, click Next to continue with the setup wizard.

2.

Read the Q Core Event Viewer End User License Agreement, and select the checkbox if terms are accepted. IMPORTANT NOTE: This product is subject to the End User License Agreement included therein. When installing the product on your hard drive, you will be requested to accept the terms of such License Agreement. If you do not accept the license agreement, you may not install or use the product in any way whatsoever.

3.

If you wish to create a shortcut on your desktop and start menu, make sure that the relevant checkbox is selected.

4.

Click Install to continue with the setup wizard.

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6.

Once the installation . is complete click Finish. A folder with the Event Viewer software and the DFU is created.

Uninstalling the Event Viewer Software > To Uninstall the Event Viewer software from your computer:

1.

Open the Windows Control Panel.

2.

In Control Panel, double click Add or Remove Programs / Uninstall a Program.

3.

Select the Event Viewer software, and click Remove/Uninstall.

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Working with the Event Viewer Software The following procedure explains how to connect, filter and download events from the Sapphire pump to your PC. > To connect the Sapphire pump to the Event Viewer software

1. 2. 3. 4.

Turn the Sapphire pump on. Then, using the Communication Cable, connect the pump to the computer. Double click the Event Viewer icon, created on your desktop. The "RS232 Communication Ports" window appears with a list of available ports displayed. Select a port from the list, and then click OK. The Event Viewer screen appears, displaying the serial number of the pump on the upper left corner of the window.

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If the pump is not prorerly identified properly by the Event Viewer, a "No Device" message will be displayed on the upper left corner of the window.

•

If this occurs: • Verify that the pump is connected to the selected port. • If the pump is connected to the selected port: • Exit the Event Viewer. • Disconnect the pump from the Communication Cable. • Repeat steps 1 through 4 from “To connect the Sapphire pump to the Event Viewer software"in page 7.

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> To filter events in the E Event Viewer

Events may be filtered by Event Code, Time, Description or Priority. This action is available before or after the events have been downloaded from the pump. Note that by default, the Event Time filter is activated on the last 7 day If no additional filtering is required, proceed to "To download and export events from the pump" in page 11.

1. In the upper right corner of the Event Viewer screen, click Filters.

2.

To select the desired filters, enter the required condition in the relevant line, and then check the "Is Active" checkbox. In the following example, only the events that occurred between October 5 and October 13, 2015 will be downloaded.

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When filtering by Priority, Events can be filtered by the following Priority number:

• 0 (Red) - Fatal error (Events: 1,2,3,4,5,118,119) • 1 (Pink) - Fault (Events: 7,8,9,10,11,12,13,14,17,26,31,129,132,157,158) • 2 (Dark Orange) - Message (Events: 6,15,16,18,19, 22, 24) • 3 (Light Orange) - Service message (Events: 20,21,111) • 4 (Purple) - Notification (Events: 27,28) • 5 (Yellow) - Service notification (Events: 25,30,112) • 6 (Green) - Information (Events: all events which are not included in one of the other categories

3. Click OK. The Filters dialog box closes.

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> To download and export events from the pump E:E

1. At the top of the Event Viewer screen, click Load from pump. The caption of the button changes to Stop loading and the download begins. As the download progresses, events are displayed on the Event Viewer sceen. Once the download is completed, the caption on the button changes back to Load from pump. The downloaded events can be sorted by clicking Sort or by clicking on the Time, Code, Description or Source column title. 2. To export the downloaded events to Excel, click Export as Excel and then save the file in a folder of your choice. The file is automatically given the serial number of the pump, and the date and time it was saved. However, it is recommended to give the file a relevant name that includes the institution name, serial number of the pump, date etc.

3.

If the Event Log file should be sent to Q Core Medical for evaluation, as defined in the Overview section of this document, please send the file to Q Core Medical by emailing it to [email protected]

4.

Disconnect the pump from the PC, and then exit the Event Viewer software.

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Event Log Tables The following tables list all Sapphire infusion pump events that are recorded to the Event Log: Power-on Events ... 12 Pump Idle Time Events ... 13 Pre-infusion and Intra-infusion Events ... 13 Operation-related Events ... 16 Settings and Options-related Events ... 18 General Events ... 23

Power-on Events The following events occur during the power-on period: Event Code

Event Description

Text on pump Screen

2

End of battery life span

End of battery life

3

Watchdog reset

Built in test failure

111

Battery life expires

Battery life expires in 2 days

112

Battery life expires

Battery life expires in 2 weeks

117

Non authorized battery

Non authorized battery inserted

118

Software failure

Software failure. Code xx (1 – Program memory, 2 – Drug library, 3 – Icons, 4 - Fonts, 5 Language 1, 6- Language 2, 7Language 3)

119

External watchdog failure

External watchdog failure

140

Time changed to

Time changed to: <xx:xx> AM/PM

193

Battery usage

Battery usage error

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Event Code

Event Description

Text on pump Screen

246

WiFi malfunction

WiFi module communication malfunction

250

System monitoring used to monitor unrecovered failures in client site

System monitoring

Pump Idle Time Events The following events occur while the pump is idle (not during an infusion): Event Code

Event Description

Text on pump Screen

18

Pump unattended

Pump unattended

248

Time synchronization

Difference of +/- xx days and xx:xx:xx h:min:sec Server time from displayed time

249

Auto program

Auto program was accepted by user

257

Auto program

Auto program was rejected by user

Pre-infusion and Intra-infusion Events The following events occur before and during an infusion:

Event Code

Event Description

Text on pump Screen

5

Inconsistent flow/Pumping mechanism

Faulty pumping mechanism or inconsistent flow <xx>

7

Low input pressure

Upstream occlusion

9

Output Occlusion

Downstream occlusion

10

Administration set misplaced

No administration set loaded

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Event Code

Event Description

Text on pump Screen

12

Air in Line

Air in line

13

Faulty air Detector

Air detector failure

14

Battery depleted

Depleted battery

16

Door open

Door of administration cassette open

17

External Communication Error

External communication error

20

Certification due within 2 days

Calibration due in <xx> days.

21

Certification due now Certification date arrived/ passed

Calibration due now

25

Certification due within 2 weeks

Next calibration due in 2 weeks.

26

Low battery voltage for high rates

Low battery for rate over 800 mL/h

28

Treatment near end

Treatment near end

29

Delayed KVO (may appear only when ADP/ EDHR is in control of a pump)

KVO during Delayed Start changed to: <xx.x> mL/h

31

Incorrect pressure value reading

Incorrect pressure value reading

36

Wireless network connection

Pump is connected to wireless network

40

Accumulated Air in Line

Accumulated air in line

42

VI Reset

VI Reset XXXX mL

82

Continuous rate, Soft limit override

Continuous rate, soft limit override: <xxx> mL/h

102

Pump Bolus key pressed

Pump bolus key pressed

103

Bolus handle key pressed

Bolus handle key pressed

127

Wireless network connection

Pump was disconnected from wireless network

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Event Code

Event Description

Text on pump Screen

129

Check for Occlusion

Possible occlusion; infusion started with clamps closed

131

Auto-KVO changed

Auto-KVO changed to: <xx.x> mL/h

132

Unknown occlusion

Possible occlusion; infusion started with clamps closed

136

Secondary VI Reset

Secondary VI Reset XXXX mL

139

Infusion near end

Infusion near end alarm set to: <xx> min

169

Power save mode state

Power save mode state: <error code> (0 – Entering stop mode, 1 – Failed to enter stop mode, 2 – Exit stop mode On/Off button pressed, 3 – Exit stop mode Stop button pressed, 5 – Exit stop mode Pump request, 6 – Exit stop mode One Minute Before Step/ State Changed)

184

Automatic restart

Automatic restart after downstream occlusion

234

Catheter bucket changing

Catheter bucket changed from XX to YY

240

Catheter hysteresis

Catheter hysteresis conditions found: XX A/D

244

MedNet connection

Pump is connected to MedNet

245

MedNet connection

Pump was disconnected from MedNet

261

Loading dose complete

Loading Dose complte. Volume infused: XX.X mL

262

Loading Dose quit

Loading Dose quit prematurely. Volume infused: XX.X mL

263

Loading Dose paused

Loading Dose paused

264

Loading Dose started

Loading Dose started

265 270

Accumulated VI Reset

Accumulated VI Reset XXXX mL

Environmental light

Excessive environmental light

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Operation-related Events The following events occur during specific pump operations, such as priming, starting an infusion, delivering a bolus, etc.: Event Code

Event Description

Text on pump Screen

24

Treatment completed

<Delivery mode> treatment completed

32

Bolus started Rate: XXX mL/h

Bolus started rate: <xxx> mL/h

33

Bolus stopped Volume infused: XX.X mL

Bolus stopped; volume infused: <xx.x> mL

34

Bolus finished Volume infused: XX.X mL

Bolus finished; volume infused: <xx.x> mL

41

Delayed start

Delayed start set to: <xx:xx:xx>

56

Power off

Power off

57

Power on

Power on

68

Clinician Bolus started

Clinician bolus started

71

Clinician Bolus complete. Volume infused: XX.X mL

Clinician Bolus complete. Volume infused: XX.X mL

73

New Infusion started

New infusion started

104

Bolus started

Bolus started

105

Demand Bolus Complete. Volume infused: XX.X mL

Demand Bolus complete. Volume infused: XX.X mL

108

Prime started

Prime started

109

Prime stopped

Prime stopped

110

Prime finished

Prime finished

122

Started from secondary bag

Started from secondary bag

124

Started from primary bag

Started from primary bag

130

Infusion Info

Infusion ended info: VTBI left = xxxx, VI=xxx, Time=xx:xx:xx, Rate=xxx.x (or last rate).

147

Infusion started with delay

Infusion started with delay (KVO = X mL/h)

159

Continued from primary bag

Continued from primary bag

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Event Code

Event Description

Text on pump Screen

160

Continued from secondary bag

Continued from secondary bag

161

Secondary line added

Secondary line added

163

Power on (battery supply)

Power on (battery supply)

164

Demand Bolus quit prematurely. Volume infused: XX.X mL

Demand Bolus quit prematurely. Volume infused: XX.X mL

165

Clinician Bolus quit prematurely. Volume infused: XX.X mL

Clinician Bolus quit prematurely. Volume infused: XX.X mL

166

Demand Bolus paused

Demand Bolus paused

167

Clinician Bolus paused

Clinician Bolus paused

172

Certification succeeded

Pump passed certification

173

Certification failed

Pump failed certification

175

Pausing bolus was not confirmed

Pausing bolus administration was attempted but not confirmed

176

Pausing infusion was not confirmed

Pausing infusion was attempted but not confirmed

177

Turn off while running was not confirmed

Turn off while running was attempted but not confirmed

178

Turn off was not confirmed

Turn off was attempted but not confirmed

179

Unlock screen was not confirmed

Unlock screen was attempted but not confirmed

182

Continue infusion was not confirmed

Continue infusion was attempted but not confirmed

183

Continue bolus was not confirmed

Continue bolus administration was attempted but not confirmed

202

Repeat last infusion

Last treatment was repeated

209

Infusion started with delay

Infusion started with delay (No KVO)

210

KVO of x mL/h was ended

KVO of x mL/h was ended

217

Intermittent dose complete

Intermittent dose complete Volume infused: XX.X <units>

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Event Code

Event Description

Text on pump Screen

219

Standby mode started

Standby mode started

220 221 222

Standby mode ended Immediate Taper down New treatment wizard initiated

Standby mode ended Pump stopped with immediate taper down New treatment wizard initiated

223

Bolus wizard initiated

Bolus wizard initiated

224

Prime wizard initiated

Prime wizard initiated

225

Secondary line wizard initiated

Secondary line wizard initiated

226

Programing was cancelled

Programing was cancelled

231

Delayed start finished

Delayed start finished

232

Preset Programs removal

Preset Programs were removed

238 239

External battery External battery

External Btteries Connected External Btteries disconnected or depleted

243

Drug Library removal

Drug Library was removed

Settings and Options-related Events The following events occur when pump configuration options are set: Event Code

Event Description

Text on pump Screen

23

Backlight

Backlight set to: On/Off/Partial

35

Key volume

Keys volume set to: <x>

37

Allow delayed start

Allow Delayed start set to: On/Off

38

Bolus rate

Default bolus rate set to: <xxx> mL/h

39

Accumulated Threshold

Accumulated threshold set to: <xxx>

46

Programmed treatment

Allow load pre-programmed treatments set to: <xx>

48

Pump unattended

Pump unattended set to: <xx>

51

Delivery mode changed to: X

Delivery mode changed to: <x>

52

Occlusion level changed to: XX.X X

Occlusion level changed to XX.XX

53

Occlusion units set to: X

Occlusion units set to: <x>

54

Single Bubble set to: X

Single bubble set to: <x>

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Event Code

Event Description

Text on pump Screen

55

Accumulated Bubble set to: X

Accumulated bubble set to: <x>

58

Authorization level set to: X

Authorization level set to: <x>

59

Alarm Volume set to: X

Alarm Volume set to: <x>

60

Speaker interval set to: X

Speaker interval set to: <x>

61

Reset system set to factory defaults

Reset system set to factory defaults

62

Language changed to: X

Language changed to: <x>

63

Time changed to: XX:XX

Time changed to: <xx:xx>

64

Date changed to: XX/XX/XX

Dated changed to: <xx/xx/xx>

65

New drug library

New drug library file uploaded: xxxxxx

67

Dose units changed to: X

Dose unit changed to: <x>

69

Clinician Bolus Amount set

Clinician bolus amount set to: <xx.xxx>

72

Bolus rate set to: XXX.X mL/h

Bolus rate set to: <xxx.x> mL/h

76

VTBI set to: XXXX mL

VTBI set to: <xxxx> mL

77

Rate set to: XXX mL/h

Rate set to: <xxx.x> mL/h

78

Dose set to: XXX

Dose set to: <xxx>

79

Interval set to: XX:XX h:min

Interval set to: <xx:xx> hr:min

81

Infusion Period set to: XX:XX h:min

Infusion period set to: <xx:xx> hr:min

83

KVO set to: XX.X mL/h

<Delivery mode> KVO set to: <xx.x> mL/h

84

KVO options set to XX.X [units] (for intermittent)

KVO options set to XX.X [units]

85

Taper Up set to: XX:XX h:min

Taper up set to: <xx:xx> hr:min

86

Taper Down set to: XX:XX h:min

Taper down set to: <xx:xx> hr:min

87

Plateau Rate calculated to: XXX.X mL/h

Plateau rate calculated to:< xxx.x> mL/h

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Event Code

Event Description

Text on pump Screen

90

Concentration set to: XX.X X /mL

Concentration set to: <xx.xx> /mL

92

Patient Weight set to: XXX kg

Patient weight set to: <xxx> kg

95

Drug concentration selected to: XX.X X

Drug concentration selected to: <xx.xx>

96

Bolus Lockout set to: XX:XX h:min

Bolus lockout set to: <xx:xx> h:min

97

Max Bolus per hour set to: XXX

Number of Boluses per x h(s) set to: xxx (x = 1 or 4)

98

Continuous rate set to: XXX.XX mL /h

Continuous rate set to: <xxx.xxx> /h

99

Demand Bolus set to: XXX.XX X

Demand bolus set to: <xx.xxx>

100

Demand Bolus calculated

Demand Bolus calculated to: <xxx.xx>

101

Rate calculated

Continuous rate calculated to: <xxx.xx>/h

120

Secondary VTBI set to: xxxx mL

Secondary VTBI set to: <xxxx> mL

121

Secondary rate set to: xxx.x mL/h

Secondary rate set to: <xxx.x> mL/h

125

Password changed

Password(s) were changed

134

Infusion type

Infusion type set to <x>

135

Limit Period settings

Limit Period set to: x h(s) (x = 1 or 4)

137

Patient ID

Patient ID set to: xxxxxxxxxx PATIENT for 'null' Patient ID

138

US format

US format set to: On/Off

141

Air detection has been set to Off

Air detection has been set to Off

142

New patient

New patient set to: On/Off

143

Loading dose

Loading dose set to: <xx>

144

Allow loading dose

Allow loading dose set to: <xx>

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