Sapphire R15 Setup and Mid-Infusion Actions Ver 01 May 2019

SETUP ACTIONS

The information provided here does not replace the SapphireTM user manual

Charging the Sapphire battery • The Sapphire pump operates on

a rechargeable battery power. • It is important to push in the charger’s

connector (red dot or arrow) in front of the arrow on the pump. DO NOT TWIST THE CONNECTOR • To disconnect the connector from the pump or splitter,

pull metal snap and release • Charger LED indicates battery charging status • Blinking, indicates battery is charging Steady on - Pump is

connected to main power, and the battery is fully charged The Sapphire bolus handle connection is identical, and it must be connected directly to the pump

PULL HERE

Priming the Sapphire set

DO NOT PULL HERE

• The Sapphire set can be primed via the pump, some sets can

also be primed manually (non-PAV sets) • It is possible to prime with the pump before or after

programming the infusion, in all delivery modes • The priming can be interrupted at any point

1. Before / after programming

2. Disconnect the set from the patient

3. Priming starts, countdown time is displayed

4. Prime ends., confirm with OK. Repeat until all air is discarded

• When set to on, Prime reminder pops a message to the user to prime the set

before starting infusion • The volume used for prime is not reduced from the volume to be infused

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Changing the delivery mode Upon turn on, the Sapphire pump is automatically set to the last delivery mode used. To select a different delivery mode: • From the start up screen, select Options • From the options screen, select Delivery mode • Enter the High code, and press OK • Select the required delivery mode • The pump shows the start up screen

The delivery mode is displayed on upper right corner, next to the battery icon

Quick Start Options Quickly start an infusion by using one of the quick start options. Option 1 – Repeat Last Infusion 1. Select Repeat Last Infusion 2. Review and confirm the program 3. Prime the set 4. Press Start to start the infusion Option 2 – PreSet

1. Select PreSet Programs 2. Select the program name from the list 3. Review and confirm the program 4. Prime the set 5. Press Start to start the infusion Repeat is used only for the same patient. The pump retains all the information from previous infusions (volumes infused, bolus history, lockout time)

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MID-INFUSION ACTIONS

The information provided here does not replace the SapphireTM user manual

Locking and Unlocking the Pump The pump can be locked to avoid unintentional or unauthorized touching of the screen. Locking the Pump

Unlocking the Pump

No Code needed to unlock Code needed to unlock

The pump can be unlocked with any code level, functions will be limited according to the code level entered. When Auto Patient Lockout is enabled, Paitent Lockout will be reactivated within 30 seconds.

Modifying an active Infusion Program 1. Unlock the pump to modify parameters 2. To modify a PCA/PCEA infusion, pause the pump first 3. TPN infusion parameters cannot be changed during infusion

From running screen Direct, single parameter change 1. Press the parameter to be modified 2. Enter the new value 3. PCA/PCEA/PIEB : Press Request Continue 4. Press OK to confirm 5. If required, lock the pump

From View/Edit menu 1. Press the View/Edit key 2. Select the parameter to be modified 3. Enter the new value 4. As needed select additional parameters to be modified 5. PCA/PCEA/PIEB : Press Request Continue 6. Press OK to confirm 7. If required, lock the pump Page 4/8

Values Infusion Program During infusion the entire infusion program can be viewed on the Infusion values menu. To access infusion values during infusion: • Press View/Edit key • Select View system option • Press the infusion values row • The values shown are the last programmed for

the treatment, VTBI is the current remaining VTBI • Parameters cannot be edited in this menu

Changing bag If additional volume needs to be programmed to continue a running infusion, do one of the following: 1. Change the the VTBI - Before infusion ended message (see modifying infusion program section) 2. Use Repeat Last option - After infusion ended message (see quick start options)

Stopping the Pump Stopping the pump can be done from the screen or from the hard key. From the screen: • Unlock if needed • Press Request Pause • Press OK to pause the pump

From the hard key: • Press the STOP hard key • Press OK to pause the pump • If the pump remains paused longer than the

time set for unattended alarm, the alarm will be triggered. • To keep the pump paused for a long period of time without alarming, power off the pump without quitting the program

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MID-INFUSION ACTIONS

The information provided here does not replace the SapphireTM user manual

Turning Off the Pump (Quit infusion or Resume) The pump can be turned off at any time by pressing the On/Off hard key and confirming on the screen. During infusion, the pump can retain the infusion status and resume it at a later time Turn off without resuming later 1. Pause the infusion 2. Press Quit 3. Press Quit infusion 4. Press On/Off hard key 5. Press OK To resume

1. Press On/Off hard key 1. Press OK to resume infusion 2. Press request continue 3. Press OK to continue infusion

Troubleshooting Alarms When the pump detects an issue with the infusion, it stops the infusion and alarms. To resolve the issue and resume the infusion 1. Press Mute to silence the alarm for 2 minutes 2. Follow the instructions on the screen to resolve the issue 3. Press OK to dismiss the alarm 4. Press Request continue 5. Press OK to confirm and restart the infusion

Issue detected

Resolution instructions

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MID-INFUSION ACTIONS PCA/PCEA/PIEB The information provided here does not replace the SapphireTM user manual

Giving a Clinician Bolus in PCA / PCEA / PIEB infusions 1. Press View/Edit 2. Select C.bolus 3. Enter the High level code and press OK 4. Enter the bolus dose to be given and press OK 5. Press OK to start the bolus A clinician bolus can be given only when the infusion is in progress. The bolus rate is predetermined in the pump settings.

Delivery History 1. Press the View/Edit key 2. Select Delivery history When pump is locked, the delivery history menu is available from the running screen, no need to unlock Total amount of medication delivered since infusion started The number of hours during which the bolus events below occurred To change this time period, click the > and enter a different number of hours

Total number of boluses delivered / patient bolus requests

Amount of medication delivered via boluses only, clinicians, patient and sum

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MID-INFUSION ACTIONS TPN The information provided here does not replace the SapphireTM user manual

Immediate Taper Down If the pump has to be stopped in the middle of a TPN infusion, the option to apply the programmed taper down or stop at once is available. The option of taper down is available during the plateau rate. To activate the taper down: 1. Press the Taper down key 2. Select Immediate Taper Down 3. Press OK to start taper down

15025-050-0071 | Rev.00 / 05.2019

When the pump is set to high code, the user can adjust the taper down time

Q Core Medical Ltd 29 Yad Haruzim St., P.O.Box 8639 Netanya 4250529, Israel T +972.73.2388888 F +972.73.2388800 [email protected]